Compounding: Inspections, Recalls, and other Actions (USA)

Abrams Royal Pharmacy, Dallas, TX

• Warning Letter (7/14/2014)
• 483 Issued 12/20/2013 (PDF – 5.3MB)
• Firm Press Release: Abrams Royal Pharmacy Issues Voluntary Nationwide Recall of All Lots of Unexpired Sterile Products Due to Lack of Sterility Assurance (12/18/2013)

Absolute Pharmacy, LLC, Lutz, FL

• 483 Issued 11/19/2014

Advanced Care Infusion-Shelby (see Tri-Med, Inc.)

Advanced Pharma, Inc., Houston, TX

• 483 Issued 03/17/2014 (PDF - 638KB)

Advanced Physician Solutions, Inc., N Hollywood, CA

• 483 Issued 01/16/2015 (PDF - 2.4MB)

Advanced Specialty Pharmacy, Bessemer, AL (dba Meds IV)

• Warning Letter (03/16/2012)

Aerosol Science Laboratories Inc., Camarillo, CA

• Warning Letter (10/29/2008)

Alexander Infusion, LLC, New Hyde Park, NY (dba Avanti Health Care Services)

• Warning Letter (3/27/2015)
• 483 Issued 07/09/2014 (PDF - 1.4MB)

Alexandria Medical Arts Pharmacy & Compounding Laboratory, Alexandria, VA (see J & F International Inc.)

ALK-Abello, Inc., Port Washington, NY

• 483 Issued 02/25/2014 (PDF - 1.3MB)

Ambient Healthcare of Central Florida Inc., Ocala, FL

• 483 Issued 9/15/2014 (PDF - 637KB)

American Hormones, Inc., Wappingers Falls, NY

• Warning Letter (01/10/2008)

American Specialty Pharmacy, Plano, TX

• 483 Issued 12/19/2014

Americare Compounding, LLC, Garden City South, NY

• Warning Letter (04/22/2014)
• 483 Issued 6/19/2013 (PDF – 754KB)

Ameridose, LLC, Westborough, MA

• FDA News Release: FDA reports voluntary recall of all Ameridose drugs products (10/31/2012)

Anazaohealth Corporation, Las Vegas, NV

• 483 Issued 01/30/2015 (PDF - 2MB)

Anazaohealth Corporation, Tampa, FL

• Referral Letter to Florida Board of Pharmacy Issued 2/21/2014 (PDF - 375KB)
• 483 Issued 2/22/2013 (PDF - 857KB)

ApothéCure, Inc., Dallas, TX

• 483 Issued 4/17/2013 (PDF - 1.6MB)
• Firm Press Release: ApothéCure, Inc. Recalls All Lots of All Sterile Products Compounded, Repackaged, and Distributed by ApothéCure, Inc. Due to Sterility Assurance Concerns (4/15/2013)

Avanti Health Care Services, New Hyde Park, NY (see Alexander Infusion, LLC)

Avella of Deer Valley, Inc, Phoenix, AZ

• Warning Letter (1/17/2014)
• Firm Press Release: Avella Specialty Pharmacy Issues Voluntary Nationwide Recall of Two Medications Due to Concerns of Sterility Assurance at Testing Vendor (9/9/2013)
• 483 Issued 2/25/2013 (PDF - 1010KB)

Axium Healthcare Pharmacy (dba Balanced Solutions Compounding), Lake Mary, FL

• Warning Letter (7/16/2013)
• 483 Issued 3/15/2013 (PDF - 638KB)
• Firm News Release: Balanced Solutions Compounding Pharmacy, LLC. Announces a Voluntary Nationwide Recall of All Sterile Compounded Products Due to a Lack of Sterility Assurance (04/17/2013)

Balanced Solutions Compounding, Lake Mary, FL (see Axium Healthcare Pharmacy)

Banner Pharmacy Services, LLC, Chandler, AZ

• 483 Issued 3/20/2015 (PDF - 1.8MB)

Beacon Hill Medical Pharmacy, P.C. (dba Rxtra Solutions), Southfield, MI

• Warning Letter (09/24/2014)
• 483 Issued 7/19/2013 (PDF – 2.7MB)
• Firm Press Release: Beacon Hill Medical Pharmacy, P.C. (dba Rxtra Solutions) Issues Voluntary Nationwide Recall of Certain Sterile Products Due to a Question of Sterility Assurance (7/31/2013)
  

Bellevue Pharmacy Solutions, St Louis, MO

• Warning Letter (01/14/2008)

BioScrip Pharmacy (NY), Inc., Lake Success, NY

• 483 Response Dated 10/10/2014 (PDF - 1.3MB)
• 483 Issued 9/19/2014 (PDF - 1.9MB)

Blue Ridge Pharmacy and Compounding Center, Raleigh, NC

• Warning Letter (4/30/2014)
• 483 Issued 10/23/2013 (PDF – 589KB)

Brookfield Medical/Surgical Supply, Inc., Brookfield, CT

• 483 Issued 4/9/2015 (PDF - 1.7MB)

Brookfield Prescription Center, Inc. (dba MD Custom Rx), Brookfield, WI

• Warning Letter (5/2/2014)
• 483 Issued 12/13/2013 (PDF – 5MB)

Brown's Compounding Center, Inc., Englewood, CO

• 483 Issued 4/27/2015 (PDF - 604KB)
• 483 Issued 8/11/2014 (PDF - 580KB)

Burklow Pharmacy, Inc., Pace, FL

• 483 Issued 3/4/2015 (PDF - 53KB)

California Pharmacy and Compounding Center, Newport Beach, CA

• 483 Issued 10/17/2014 (PDF - 544KB)
• 483 Issued 08/25/2014 (PDF - 2.8MB)

Cantrell Drug Company, Little Rock, AR

• Warning Letter (1/15/2015)
• Amended 483 Issued 11/4/2013 (PDF - 6.5MB)

Central Admixture Pharmacy Services, Inc. (CAPS), Woburn, MA

• 483 Issued 2/20/2014 (PDF - 1.9MB)
• 483 Issued 1/29/2013 (PDF - 11.7MB)

Central Admixture Pharmacy Services, Wallingford, CT

• 483 Issued 2/19/2013 (PDF - 8MB)

Central Admixture Pharmacy Services, Inc. (CAPS), Allentown, PA

• 483 Issued 2/11/2015 (PDF - 888KB)
• 483 Issued 6/11/2014 (PDF - 2.1MB)

Central Admixture Pharmacy Services, Inc. (CAPS), Homewood, AL

• 483 Issued 3/7/2013 (PDF - 600KB)

Central Admixture Pharmacy Services, Inc., (CAPS), Kansas City, MO

• 483 Issued 2/28/2013 (PDF - 697KB)

Central Admixture Pharmacy Services, Inc., (CAPS), Livonia, MI

• 483 Issued 6/25/2014 (PDF - 928KB)
• 483 Issued 2/28/2013 (PDF - 790KB)

Central Admixture Pharmacy Services, Inc. (CAPS), San Diego, CA

• 483 Issued 08/08/2014 (PDF - 1.5MB)

Central Admixture Pharmacy Services, Inc., (CAPS), Chicago, IL

• 483 Issued 2/22/2013 (PDF - 974KB) 

Civic Center Pharmacy, Scottsdale, AZ

• 483 Issued 10/9/2014
• Warning Letter (12/16/2008)

Clinical Apothecaries, Medina, OH

• Referral Letter to the Ohio Board of Pharmacy Issued 5/30/2014 (PDF - 1.1MB)
• 483 Issued 11/20/2013 (PDF - 660KB)

Clinical Specialties Compounding Pharmacy, Augusta, GA

• Warning Letter (6/27/2014)
• 483 Issued 4/2/2013 (PDF - 5.4MB)
• Firm News Release: Clinical Specialties Compounding Pharmacy Recalls All lots of Sterile Products Repackaged and Distributed by Clinical Specialties Compounding Due to Lack of Sterility Assurance (03/20/2013)

Coastal Meds, LLC., Biloxi, MS

• 483 Issued 11/10/2014 (PDF - 691KB)

College Pharmacy Incorporated, Colorado Springs, CO

• 483 Issued 5/28/2015 (PDF - 1MB)
• 483 Issued 3/15/2013 (PDF - 1.3MB)

Complete Pharmacy and Medical Solutions, LLC, Miami Lakes, FL

• 483 Issued 8/12/2014 (PDF - 1.4MB)

The Compounding Shop, St. Petersburg, FL

• Warning Letter (8/12/2014)
• FDA Alert: FDA Alerts Patients and Health Care Providers Not to Use Budesonide Solution from The Compounding Shop (9/27/2013)
• 483 Issued 9/3/2013 (PDF - 97KB)
• Firm Press Release: In Cooperation with FDA, The Compounding Shop, LLC Declares a Voluntary Recall of All Lots of Sterile Compounded Products Due to a Lack of Sterility Assurance Distributed Within its Local Market Area (05/06/2013)
• Amended 483 Issued 3/25/2013 (PDF - 10MB)
• 483 Issued 3/22/2013 (PDF - 1.3MB)
• FDA Press Release: FDA alerts health care providers of lack of sterility assurance of drug products from The Compounding Shop (03/08/2013)

Coram Healthcare Corp. of Indiana, Crown Point, IN

• 483 Issued 12/16/2014

Creative Compounds, Wilsonville, OR (see Oregon Compounding Centers, Inc.)

Custom Compounding Center, Little Rock, AR

• 483 Issued 4/9/2015 (PDF - 603KB)

Custom Compounding Centers, LLC, Los Alamitos, CA

• 483 Response 10/17/2014 (PDF - 637KB)
• 483 Response 10/09/2014 (PDF - 225KB)
• 483 Response 09/18/2014 (PDF - 844KB)
• 483 Issued 8/28/2014 (PDF - 457KB)
• Warning Letter (5/15/2013) 
• 483 Issued 12/13/2012 (PDF - 577KB) 

Custom RX LLC, dba Custom RX Compounding Pharmacy, Richfield, MN

• 483 Issued 8/28/2014 (PDF - 775KB)

Delta Pharma, Inc., Ripley, MS

• Warning Letter (12/9/2014)
• 483 Issued 10/2/2013 (PDF - 857KB) 

Designer Drugs, Chattanooga, TN (see The Wellness Center Pharmacy, Inc.)

Diamond Pharmacy, LLC, Houston, TX

• 483 Issued 5/15/2015 (PDF - 1.8MB)

Diversified Pharmacy Inc., (dba University Compounding Pharmacy), Troy, MI

• 483 Issued 11/13/2014 (PDF - 869KB)

DNA Pharmacy Services, Inc., (dba Palm Beach Compounding), Jupiter, FL

• 483 Issued 8/13/2014 (PDF - 251KB)

Downing Labs, LLC (NuVision Pharmacy), Dallas, TX

• FDA Requested Recall Letter Issued 9/9/2014 (PDF – 941KB)
• FDA News Release: FDA reminds health care professionals and consumers not to use sterile products from Downing Labs/NuVision Pharmacy of Texas (9/9/2014)
• 483 Response 08/20/2014 (PDF - 4.2MB)
• 483 Response 08/06/2014 (PDF - 4MB)
• FDA alerts health care professionals not to use sterile drugs from Downing Labs (aka NuVision Pharmacy)(07/18/2014)
• 483 Issued 7/16/2014 (PDF - 2.1MB)
• FDA Press Release: FDA reminds health care providers not to use sterile products from NuVision Pharmacy (08/16/2013)
• FDA Requested Recall Letter Issued 7/26/2013 (PDF – 862KB)
• FDA Press Release: FDA expands alert to health care providers about lack of sterility assurance of all sterile drug products from NuVision Pharmacy (05/18/2013)
• 483 Issued 4/17/2013 (PDF - 1.2MB)
• Firm Press Release: NuVision Pharmacy Recalls All Lots of All Lyophilized Products Compounded by NuVision Pharmacy Due to Sterility Assurance Concerns (4/15/2013)

D.R. Pharmacy, Inc., Midland, TX

• 483 Issued 3/6/2015 (PDF - 647KB)

Drugs are Us, Inc. (dba Hopewell Pharmacy), Hopewell, NJ

• Referral Letter to New Jersey State Board of Pharmacy Issued 2/21/2014 (PDF - 1.3MB)
• 483 Issued 3/21/2013 (PDF - 1.5MB)

Eastern Pharmacy, Inc., Ocala, FL

• Warning Letter (10/29/2014)
• 483 Issued 2/4/2014 (PDF - 516KB)

Eastern States Compounding Pharmacy, Littleton, NH (see Northern New England Compounding Pharmacy)

Edge Pharmacy Services, LLC, Colchester, VT

• 483 Issued 8/20/2014 (PDF - 923KB)

Exela Pharma Sciences, LLC, Lenoir, NC

• 483 Issued 11/21/2014 (PDF - 406KB)

Fallon Wellness Pharmacy, LLC, Latham, NY

• 483 Issued 3/10/2015 (PDF - 1MB)

Farmacia Le Salud Inc., Caguas, PR

• Warning Letter (03/26/2008)

Foundation Care LLC, Earth City, MO

• Referral Letter to Missouri Board of Pharmacy Issued 2/26/2014 (PDF - 396KB)
• 483 Response Dated 4/9/2013 (PDF - 1020KB)
• 483 Issued 3/19/2013 (PDF - 867KB)

Franck's Compounding Lab, Ocala, FL (see Franck's Lab, Inc.)

Franck's Lab, Inc., Ocala, FL (dba Franck's Compounding Lab)

• Warning Letter (07/09/2012)

Franck's Lab, Inc., Ocala, FL (dba Trinity Care Solutions)

• 483 Issued 5/23/2014 (PDF - 856KB)

Freedom Pharmacy, Orlando, FL (see HHCS Pharmacy, Inc.)

FVS Holdings, Inc. (dba Green Valley Drugs), Henderson, NV

• Warning Letter (8/30/2013)
• Firm Press Release: Green Valley Drugs Announces Voluntary Nationwide Recall of All Lots of All Sterile Products Compounded, Repackaged, and Distributed by Green Valley Drugs Due to Quality Control Concerns (4/5/2013) 
• 483 Issued 3/15/2013 (PDF - 4.9MB)  

Grandpa's Compounding Pharmacy, Inc., Placerville, CA

• Warning Letter (5/2/2014)
• 483 Issued 9/10/2013 (PDF - 1.1MB) 

Green Hills Health and Wellness Pharmacy Inc., Nashville, TN

• 483 Response dated 11/11/2014 (PDF - 4.1MB)
• 483 Issued 10/22/2014 (PDF - 727KB)

Green Valley Drugs, Henderson, NV (see FVS Holdings, Inc.)

Healix Infusion Therapy, Inc., Sugar Land, TX

• 483 Issued 5/16/2014 (PDF - 628KB)

Health Dimensions, Inc., Farmington Hills, MI

• Referral Letter to the Michigan State Department of Licensing and Regulatory Affairs (LARA) Issued 5/21/2015 (PDF - 545KB)
• 483 Response Dated 8/29/2014 (PDF - 1.5MB)
• 483 Issued 8/8/2014 (PDF - 613KB)

Health Innovations Pharmacy, Inc., Southern Pines, NC

• 483 Issued 2/27/2015 (PDF - 805KB)

HHCS Pharmacy, Inc. (dba Freedom Pharmacy), Orlando, FL

• Warning Letter (5/14/2015)
• 483 Issued 7/28/2014 (PDF - 1.7MB)

Hieber's Pharmacy, Pittsburgh, PA

• 483 response issued 10/17/2014 (PDF - 6.4MB)
• 483 Issued 9/18/2014 (PDF - 541KB)

Home Infusions Solutions, Inc., Horsham, PA

• Referral Letter to the Pennsylvania State Board of Pharmacy Issued 3/27/2014 (PDF - 144KB)
• 483 Issued 5/21/2013 (PDF – 573KB) 

Home Intensive Care Pharmacy, Inc., San Antonio, TX

• Warning Letter (1/22/2014)
• 483 Issued 3/1/2013 (PDF - 1.1MB)

Hopewell Pharmacy and Compounding Center, Hopewell, NJ (dba Drugs Are Us, Inc.)

• Referral Letter to NJ Board of Pharmacy Issued 02/21/2014 (PDF - 1.3MB)
• Warning Letter (09/28/2009)

HRI Pharmacy, Warrenville, IL (see National Prescription Services)

Hunter Holmes McGuire Veterans Admin Medical Center, Richmond, VA

• 483 Issued 3/11/2015 (PDF - 496KB)

Infupharma, LLC, Hollywood, FL dba President Pharmacy

• 483 Issued 2/5/2015 (PDF - 685KB)
• Warning Letter (07/30/2012)

InfuScience a subsidiary of Bioscrip, Mount Pleasant, SC

• 483 Issued 5/15/2015 (PDF - 973KB)

Infusion Options, Inc., Brooklyn, NY

• 483 Issued 4/23/2014 (PDF - 2.3MB)

Infusion Partners (subsidiary of BioScrip), Sharpsburg, PA

• 483 Response Dated 1/9/2015 (PDF - 7.6MB)
• Amended 483 Issued 12/10/2014 (PDF - 976KB)
• 483 Issued 12/05/2014

Infusion System of SW Florida Inc. (dba Myerlee Pharmacy), Fort Myers, FL

• 483 Issued 12/22/2014 (PDF - 1.6MB)

Innovative Compounding Pharmacy, Folsom, CA

• 483 Issued 4/17/2015 (PDF - 1MB)

Ionia Pharmacy, Tustin, CA

• 483 Issued 3/6/2015 (PDF - 2MB)

IV Solutions of Lubbock, Lubbock, TX (see Maxor National Pharmacy Services Corporation)

• Referral Letter to the Texas Board of Pharmacy Issued 3/18/2014 (PDF - 604KB)
• 483 Response Dated 4/2/2013 (PDF - 976KB)
• 483 Issued 3/20/2013 (PDF - 3.7MB) 

I.V. Specialty, Ltd., Austin, TX

• Warning Letter (4/21/2015)
• 483 Issued 7/22/2014 (PDF - 1019KB)

J & F International Inc., Alexandria, VA (dba Alexandria Medical Arts Pharmacy & Compounding Laboratory)

• Warning Letter (04/09/2010)

JCB Labs, LLC, Wichita, KS

• Warning Letter (7/7/2014)
• Firm Press Release: JCB Laboratories Issues Voluntary Recall of Six Drug Product Lots Due to Concerns of Sterility Assurance at Testing Vendor (8/26/2013)
• 483 Issued 2/27/2013 (PDF - 1.9MB)

John Hollis Pharmacy (see John W. Hollis, Inc.)

John W. Hollis, Inc., Nashville, TN (dba John Hollis Pharmacy)

• Response Letter (9/18/2014)
• Warning Letter (9/4/2014)
• Human Drug Product Recall (Pending Classification) for the 4/2/2014 Enforcement Report
• 483 Issued 3/21/2014 (PDF - 1.3MB)

Johnson Memorial Cancer Center, Enfield, CT

• 483 Issued 8/5/2014 (PDF - 916KB)

Jubilant HollisterStier, LLC, Spokane, WA

• 483 Issued 12/2/2014
• 483 Issued 4/15/2014 (PDF - 18MB)

Jungle Jim's Pharmacy, Fairfield, OH

• 483 Issued 1/26/2015 (PDF - 500KB)

Kings Park Slope, Inc., Brooklyn, NY

• Warning Letter (3/27/2015)
• 483 Issued 3/14/2014 (PDF - 3.2MB)

KRS Global Biotechnology, Inc., Boca Raton, FL

• 483 Issued 3/17/2014 (PDF – 735KB)

Lato Drug Company, Inc. dba Post Haste Pharmacy, Hollywood, FL

• 483 Issued 2/20/2015 (PDF - 712KB)

Lee and Company dba Lee Pharmacy, Inc., Fort Smith, AR

• Warning Letter (6/6/2014)
• 483 Issued 2/21/2013 (PDF - 2.6MB)

Lee Pharmacy, Inc., Fort Smith, AR (see Lee and Company)

LeeSar, Inc., Fort Myers, FL

• 483 Issued 08/08/2014 (PDF – 541KB)

Leiter's Cambrian Park Drugs, Inc. (dba Leiter's Compounding Pharmacy), San Jose, CA

• Warning Letter (4/14/2015)
• Amended 483 Issued 10/8/2014
• 483 Issued 10/7/2014
• 483 Response Dated 3/26/2014 (PDF - 3.6MB)
• 483 Issued 03/06/2014 (PDF - 1.3MB)
• 483 Response Dated 11/25/2013 (PDF - 5MB)
• 483 Issued 11/5/2013 (PDF - 3.8MB)

Leiter's Compounding Pharmacy, San Jose, CA (see Leiter's Cambrian Park Drugs, Inc.)

Liberty Drug and Surgical, Chatham, NJ

• 483 Issued 5/26/2015 (PDF - 926KB)

Lowlite Investments, Inc. (see OPS International, Inc.), Orlando, FL

Lowlyn Pharmacies, Inc. (dba Red Cross Drug), Blanchard, OK

• Referral Letter to Oklahoma State Board of Pharmacy Issued 2/25/2014 (PDF - 2.4MB)
• 483 Issued 3/8/2013 (PDF - 732KB) 

Main Street Family Pharmacy, Newbern, TN

• FDA Press Release: FDA resolves criminal and civil actions against Main Street Family Pharmacy (12/4/2014)
• 483 Issued 6/11/2013 (PDF - 873KB)
• FDA Statement: Update on Main Street Family Pharmacy Products: Samples of injectable methylprednisolone acetate test positive for microbial contamination (6/6/2013) 
• Firm Press Release: Main Street Family Pharmacy, LLC Issues Voluntary Nationwide Recall of All Sterile Compounded Products (5/28/2013)
• FDA Press Release: FDA alerts health care providers of adverse reactions associated with steroid injections from Main Street Family Pharmacy in Tennessee (5/24/2013) 

Marlborough Hospital, Marlborough, MD

• 483 Issued 9/17/2014

Martin Avenue Pharmacy, Inc., Naperville, IL

• Warning Letter (3/18/2015)
• Firm Press Release: Martin Avenue Pharmacy, Inc., Issues a Voluntary Multi-State Recall of All Compounded Sterile Preparations Due to a Lack of Assurance of Sterility (8/27/2014)
• 483 Issued 7/21/2014 (PDF - 1.8MB)

Maxor National Pharmacy Services Corporation (dba IV Solutions of Lubbock), Lubbock TX

McGuff Compounding Pharmacy Services, Inc., Santa Ana, CA

• 483 Issued 12/31/2014

MD Custom Rx, Brookfield, WI (see Brookfield Prescription Center)

Medaus, Inc., Birmingham, AL

• Warning Letter (1/15/2014)
• Firm Press Release: Medaus Pharmacy Initiates a Nationwide Recall of Certain Pharmacy Products due to Questions Surrounding an Independent Third Party’s Sterility Testing (9/4/2013)
• 483 Issued 3/22/2013 (PDF - 712KB)

Medi-Fare Drug & Home Health Center, Inc., Blacksburg, SC

• 483 Issued 09/12/2014 (PDF - 371KB)
• 483 Issued 06/21/2013 (PDF - 2.4 MB)
• Warning Letter issued 3/07/2013
• 483 Issued 1/18/2013 (PDF - 3.5MB)

Medi-Home Infusion Pharmacy, Irmo, SC

• Referral Letter to the South Carolina State Board of Pharmacy Issued 5/21/2015 (PDF - 820KB)
• 483 Issued 9/17/2014 (PDF - 643KB)

Medi-Stat RX, LLC, Foley, AL (see Newman Inc.)

MedPrep Consulting, Tinton Falls, NJ

• FDA Press Release: Federal Judge Enters Consent Decree with Med Prep Consulting (6/28/2013)
• 483 Issued 4/3/2013 (PDF - 6.9MB)
• Firm News Release: Medprep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of All Compounded Products Due To Potential Mold Contamination (03/20/2013) 
• FDA Press Release: FDA alerts health care providers of recall of all sterile drug products by Med Prep Consulting in New Jersey (03/18/2013)
• Firm News Release: MedPrep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of All Compounded Products Due To Potential Mold Contamination (03/17/2013)
• Firm News Release: MedPrep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of Magnesium Sulfate 2gm In Dextrose 5% In Water, 50ml For Injection Due To Mold Contamination (03/16/2013)
• Warning Letter (07/09/2010)

Meds IV, Bessemer, AL (see Advanced Specialty Pharmacy)

Montana Compounding Pharmacy and Wellness Center, Missoula, MT

• 483 Issued 5/8/2015 (PDF - 2.5MB)

Murray Avenue Apothecary, Pittsburgh, PA

• Warning Letter (01/07/2008)

Myerlee Pharmacy, Fort Myers, FL (see Infusion System of SW Florida)

National Prescription Services Inc. (dba HRI Pharmacy), Warrenville, IL

• 483 Issued 11/24/2014

Nature's Pharmacy and Compounding Center, Asheville, NC

• Warning Letter (05/09/2014)
• 483 Issued 11/22/2013 (PDF - 1MB)
• Firm Press Release: Nature's Pharmacy and Compounding Center Issues Voluntary Recall of All Sterile Compounded Products Distributed Within North Carolina Due to Lack of Sterility Assurance (11/13/2013)

Nebraska Methodist Hospital, Omaha, NE

• 483 Issued 7/14/2014 (PDF - 772KB)

New England Compounding Center, Framingham, MA

• Drug Safety Podcast: Investigation into New England Compounding Center (11/13/2012)
• News release: FDA reports conditions observed at New England Compounding Center facility (10/26/2012)
• 483 Issued (10/26/2012) (PDF - 1.72MB)
• Multistate outbreak of fungal meningitis and other infections

Newman Inc., Foley, AL (dba Medi-Stat RX, LLC)

• 483 Issued 9/18/2014 (PDF - 798KB)
• Warning Letter (06/24/2008)

Nora Apothecary and Alternative Therapies, Inc., Indianapolis, IN

• 483 Issued 8/21/2014 (PDF - 422KB)
• Warning Letter (2/14/2014)
• Firm Press Release: Nora Apothecary & Alternative Therapies Announces a Voluntary Multi-State Recall of All Sterile Compounded Products Due to a Lack of Sterility Assurance (04/22/2013)
• 483 Issued 3/21/2013 (PDF - 309KB)

Northern New England Compounding Pharmacy, LLC, dba Eastern States Compounding Pharmacy, Littleton, NH

• Referral Letter to New Hampshire State Borad of Pharmacy Issued 4/29/2015 (PDF - 117KB)
• 483 Response dated 10/08/2014 (PDF - 678KB)
• 483 Issued 9/30/2014 (PDF - 455KB)

NuVision Pharmacy, Dallas TX (see Downing Labs, LLC)

Oakdell Pharmacy, Inc., San Antonio, TX

• Warning Letter (5/27/2014)
• 483 Issued 3/1/2013 (PDF - 1.1MB)

Olympia Pharmacy, Orlando, FL (see OPS International, Inc.)

OncoMed (Onco 360), Great Neck, NY (see Sina LLC)

One Way Drug, LLC (dba Partell Specialty Pharmacy), Las Vegas, NV

• 483 Issued 5/30/2014 (PDF - 1.3MB)

OPS International, Inc. (dba Olympia Pharmacy), Orlando, FL

• 483 Issued 12/4/2014 (PDF - 1.3MB)
• Warning Letter (2/18/2014)
• Firm Press Release: Lowlite Investments, Inc. d/b/a Olympia Pharmacy Announces a Voluntary Multi-State Recall of All Sterile Compounded Products Compounded Between December 17, 2012, and March 27, 2013, Due to Concerns About Sterility Assurance (05/29/2013) 
• 483 Issued 3/21/2013 (PDF - 717KB)

Oregon Compounding Centers, Inc. (dba Creative Compounds), Wilsonville, OR

• Warning Letter (01/27/2015)
• 483 Response Dated 10/1/2014 (PDF - 5MB)
• Firm Press Release: Oregon Compounding Centers, Inc. Issues Voluntary Recall of Unexpired Sterile Products in Oregon and Washington Due to Lack of Sterility Assurance (10/9/2014)
• Amended 483 09/12/2014 (PDF - 1.9MB)
• 483 Issued 8/28/2014 (PDF - 1.7MB)

Pacifica Pharmacy, Torrance, CA

• Warning Letter (01/07/2008)

Pallimed Solutions, Inc., Woburn, MA

• Warning Letter (2/19/2014)
• Amended 483 and Cover Letter Issued 4/9/2013 and 483 Issued 3/29/2013 (PDF - 15.9MB)

Palm Beach Compounding, Jupiter, FL (see DNA Pharmacy Services, Inc.)

Panorama Compounding Pharmacy, Lake Balboa, CA

• Warning Letter (01/07/2008)

Park Compounding, Irvine, CA (see South Coast Specialty Compounding, Inc.)

Partell Specialty Pharmacy, Las Vegas, NV (see One Way Drug, LLC)

Pentec Health, Inc, Boothwyn, PA

• Warning Letter (03/07/2014)
• Firm Press Release: Pentec Health Announces Limited Voluntary Recall of Certain Compounded Prescription Therapies for Renal Patients (05/15/2013)
• 483 Issued 4/1/2013 (PDF - 924KB)

People's Pharmacy, Inc. #2, Austin, TX

• 483 Issued 7/28/2014 (PDF - 560KB)

Perry Drug Inc., Overland Park, KS

• Warning Letter (02/03/2015)
• 483 Issued 09/09/2014 (PDF – 821KB)

Pharmacy Compounding Specialties, Dallas, TX

• Warning Letter (01/07/2008)

Pharmacy Creations, Randolph, NJ

• Firm Press Release: Pharmacy Creations Issues Voluntary Recall of Four Product Lots With Limited Distribution in Florida, New Jersey, New York, and Puerto Rico Due to Potential Non-Sterility (9/4/2014)
• Warning Letter (06/23/2014)
• 483 Response Issued 9/3/2013 (PDF - 39KB)
• 483 Issued 8/19/2013 (PDF - 1.3MB) 

Pharmagen Laboratories, Silver Spring, MD

• Warning Letter (10/24/2014)

Pharmagen Laboratories, Inc, Stamford, CT

• Amended 483 Issued 08/26/2013 (PDF - 1.1MB)
• 483 Issued 08/23/2013 (PDF - 1.1MB) 

Pharmakon Pharmaceuticals, Inc. Noblesville, IN

• Warning Letter (5/21/2015)
• 483 Issued 3/13/2014 (PDF – 1.9MB)
• 483 Issued 4/08/2014 (PDF – 350KB)

PharmaLogic CSP, Inc., Bridgeport, WV

• 483 Issued 12/12/2014

Pharm D Solutions, LLC, Houston, TX

• 483 Issued 6/5/2015 (PDF - 585KB)

PharMEDium Services LLC, Memphis, TN

• 483 Issued 3/22/2013 (PDF - 10.4MB)

PharMEDium Services LLC, Edison, NJ

• 483 Issued 2/28/2013 (PDF - 2MB)

PharMEDium Services, LLC, Lake Forest, IL

• Warning Letter (7/18/14)
• Other Action: FDA letter to firm (2/5/13)

PharMEDium Service, Inc., Sugarland, TX

• 483 Issued 2/27/2013 (PDF – 1.1MB)

PharMEDium Services, LLC, Cleveland, MS

• 483 Issued 2/22/2013 (PDF – 1.9MB) 

Physician Preferred Medical, LLC, Oklahoma City, OK

• 483 Issued 2/19/2015 (PDF - 1.6MB)

Pine Pharmacy and Home Care Products Center, Inc., Williamsville, NY

• Warning Letter (2/13/2015)
• 483 Issued 12/16/2013 (PDF – 5.3MB)
• 483 Issued 7/19/2013 (PDF – 1.4MB)

Portage Pharmacy, Inc., Portage, MI

• Referral Letter to Michigan Board of Pharmacy Issued 2/25/2014 (PDF - 357KB)
• 483 Issued 3/6/2013 (PDF - 8.9MB)

Post Haste Pharmacy, Hollywood, FL (see Lato Drug Company)

Precision Pharmacy Center, LLC, Brea, CA

• 483 Issued 4/1/2015 (PDF - 608KB)

Premier Pharmacy Labs, Inc., (dba Rx Nations), Weeki Wachee, FL

• Warning Letter (4/27/2015)
• 483 Issued 5/09/2014 (PDF – 2.5MB)

President Pharmacy, Hollywood, FL (see Infupharma LLC)

RC Compounding Services, LLC, Poland, OH

• Warning Letter (7/14/2014)
• 483 Issued 2/7/2013 (PDF - 195KB)

Red Cross Drug, Blanchard, OK (see Lowlyn Pharmacies, Inc.)

Reed's Compounding Pharmacy, Tucson, AZ

• Warning Letter (01/07/2008)

Region Care, Inc., Great Neck, NY

• Warning Letter (4/8/2015)
• 483 Issued 3/20/2014 (PDF – 922KB)

Reliant Pharmacy, (see Yeung Business Solutions), Southbury, CT

Right Value Drug Stores, Inc., Hurst, TX

• 483 Issued 12/12/2014

RX3 Pharmacy, Chester, VA (see RxSouth, LLC)

Rx Formulations, Mesa, AZ (dba Zions RX Formulations)

• Referral Letter to the Arizona Board of Pharmacy Issued 3/30/2015 (PDF - 725KB)
• 483 Issued 12/2/2014 (PDF - 526KB)
• Warning Letter (8/15/2014)
• FDA Statement: FDA confirms contamination in Rx Formulations’ calcium gluconate 10% product (2/6/2014)
• 483 Issued 1/9/2014 (PDF - 1.04MB)
• FDA Statement: FDA announces Rx Formulation's voluntary recall of sterile drug products (12/13/2013) 

Rx Nations, Weeki Wachee, FL (see Premier Pharmacy Labs, Inc.)

RxSouth, LLC (dba RX3 Pharmacy), Chester, VA

• Response Letter (11/12/2014)
• Warning Letter (10/23/2014)
• 483 Issued 2/21/2014 (PDF - 5MB)
• Referral Letter to Virginia Board of Pharmacy Issued 8/13/2013 (PDF - 9.4MB)
• 483 Issued 12/14/2012 (PDF - 5.1MB)

Rxtra Solutions, Southfield, MI (see Beacon Hill Medical Pharmacy)

Saint John's Medical Plaza Pharmacy, Santa Monica, CA

• Warning Letter (01/07/2008)

SCA Pharmaceuticals, LLC, Little Rock, AR

• 483 Issued 4/01/2014 (PDF – 1.7MB)

Sina LLC, (dba OncoMed (Onco 360)), Great Neck, NY

• Referral Letter to New York State Board of Pharmacy Issued 4/21/2015 (PDF - 79KB)
• 483 Issued 8/22/2014 (PDF – 936KB)

South Coast Specialty Compounding, Inc. (dba Park Compounding), Irvine, CA

• 483 Issued 7/2/2014 (PDF - 708KB)

Specialty Compounding, LLC, Cedar Park, TX

• FDA Press Release: Federal judge enters consent decree against Specialty Compounding LLC
• 483 Issued 9/13/2013 (PDF - 9MB)
• CDC Health Advisory: Nationwide Voluntary Recall of All Products for Sterile Use from Compounding Pharmacy located in Cedar Park, Texas (8/14/2013)
• FDA Press Release: FDA announces nationwide voluntary recall of all products for sterile use from Specialty Compounding (08/11/2013)
• Firm Press Release: Specialty Compounding, LLC Issues Nationwide Voluntary Recall of All Lots of Unexpired Sterile Products Due to Reports of Adverse Events (08/09/2013)
• 483 Issued 3/22/13 (PDF – 744KB)

Specialty Medicine Compounding Pharmacy, P.C., South Lyon, MI

• 483 Issued 11/5/2013 (PDF - 3.2MB) 

Spoonamore Drug Co., Inc., Louisville, KY

• 483 Issued 2/3/2015 (PDF - 543KB)

SSM Health Care St. Louis (dba SSM St. Clare Health Center), Fenton, MO

• 483 Issued 8/14/2014 (PDF – 711KB)

SSM St. Clare Health Center, Fenton MO (see SSM Health Care St. Louis)

Steven's Pharmacy, Costa Mesa, CA

• Warning Letter (11/12/2008)

Stewart Compounding Pharmacy, Fayetteville, NC

• 483 Issued 10/10/2014 (PDF - 1.5MB)
• 483 Issued 02/26/2014 (PDF - 1.4MB)
• Warning Letter (8/21/2013)
• 483 Issued 3/25/2013 (PDF - 7.3MB) 

Summerton Drug Compounding and Dispensary, Summerton, SC

• 483 Issued 10/17/2014 (PDF - 493KB)

The Apothecary Shoppe, LLC, Tulsa, OK

• 483 Issued 3/13/2015 (PDF - 1.3MB)

The Prescription Center, Fayetteville, NC

• FDA News Release: FDA alerts health care professionals and patients not to use products from the Prescription Center pharmacy in Fayetteville, N.C.
• NCBOP Press Release: North Carolina Board of Pharmacy Announces a Recall of All Lots of Non‐ Sterile and Sterile Products Compounded, Repackaged, and Distributed by Prescription Center Between September 10, 2014 and March 10, 2015 Due to Lack of Sterility, Potency, and Stability Assurance

The Wellness Center Pharmacy, Inc. (dba Designer Drugs), Chattanooga, TN

• 483 Issued 5/28/2015 (PDF - 1.2MB)

The Wellness Pharmacy, LLC, Winchester, VA

• 483 Issued 3/12/2015 (PDF - 672KB)

Total Pharmacy Services, Houma, LA

• 483 Issued 9/30/2014 (PDF - 514KB)
• Warning Letter (2/28/2014)
• 483 Issued 5/22/2013 (PDF - 311KB) 

Transdermal Therapeutics, Inc., Birmingham, AL

• 483 Response 10/14/2014 (PDF - 952KB)
• 483 Issued 6/27/2014 (PDF - 413KB)

Triad Isotopes, Inc., Kansas City, MO

• Amended 483 Issued 1/9/2015
• 483 Issued 1/9/2015

Triangle Compounding, Cary, NC

• 483 Issued 1/16/2015 (PDF - 484KB)
• 483 Issued 9/22/2014 (PDF - 1MB)
• Warning Letter (1/14/2014)
• 483 Issued 3/1/2013 (PDF - 880KB)

Tri-Med, Inc. (dba Advanced Care Infusion-Shelby), Shelby Township, MI

• 483 Response Dated 3/12/2015 (PDF - 2.1MB)
• 483 Issued 2/23/2015 (PDF - 1.6MB)

Trinity Care Solutions, Ocala, FL (see Franck's Lab, Inc.)

UCSF Home Therapy Services, San Francisco, CA

• 483 Issued 9/12/2014 (PDF – 893KB)

Unique Pharmaceutical, Ltd., Temple, TX

• 483 Issued 1/23/2015 (PDF - 560KB)
• Firm Press Release: Unique Pharmaceuticals, Ltd. Announces a Voluntary Nationwide Recall of all Sterile Compounded Preparations Within Their Expiry Period Due to a Lack of Sterility Assurance
• FDA Statement: FDA alerts health care professionals not to use sterile drugs from Unique Pharmaceuticals
• FDA Requested Recall Letter 7/11/14 (PDF – 754KB)
• 483 Issued 6/20/2014 (PDF - 1MB)
• Amended 483 Issued 4/4/2014 (PDF - 4.3MB)
• 483 Issued 04/02/2014 (PDF - 748KB)

University Compounding Pharmacy, Troy, MI (see Diversified Pharmacy Inc.)

University Pharmacy, Inc., Salt Lake City, UT

• Referral Letter to Utah State Board of Pharmacy Issued 2/20/2014 (PDF - 240KB)
• 483 Issued 2/26/2013 (PDF - 645KB) 

US Compounding Inc., Conway, AR

• 483 Issued 3/27/2014 (PDF – 1.1MB)

US Specialty Formulations LLC, Bethlehem, PA

• 483 Issued 5/29/2015 (PDF - 1.7MB)

Vann Healthcare Services, Inc., Glasgow, KY

• 483 Issued 9/24/2014

Village Compounding Pharmacy, Houston, TX

• Warning Letter (01/07/2008)

Village Fertility Pharmacy, Inc., Waltham, MA

• Warning Letter (02/28/2014)
• 483 Issued 3/13/2013 (PDF - 393KB)  

Walgreens Infusion Services, Houston, TX

• 483 Issued 11/25/2014 (PDF - 1.1MB)

Wedgewood Village Pharmacy, Inc. Swedesboro, NJ

• Warning Letter (2/21/2014)
• 483 Issued 2/11/2013 (PDF - 10.9MB) 

Wellness Pharmacy, Inc., Birmingham, AL

• Referral Letter to the Alabama State Board of Pharmacy Issued 4/15/2015 (PDF - 581KB)
• 483 Response 10/20/2014 (PDF – 2.2MB)
• 483 Issued 9/30/2014 (PDF – 251KB)

Wells Pharmacy Network, LLC, Ocala, FL

• 483 Issued 06/19/2014 (PDF - 1MB)
• 483 Issued 03/07/2014 (PDF - 1.2MB)
• 483 Issued 07/26/2013 (PDF - 1.1MB) 

Wells Pharmacy Network, LLC, Wellington, FL

• Warning Letter (11/10/2014)

Wickliffe Pharmaceutical, Inc., Lexington, KY

•  483 Issued 5/22/2014 (PDF – 206KB)

Wiley Chemists, Inc., Santa Fe, NM

• 483 Issued 10/2/2013 (PDF - 221KB)

Wood's Pharmacy, Inc., dba The Medicine Shoppe, Boones Mill, VA

• 483 Issued 1/15/2015 (PDF 2.4MB)

Yeung Business Solutions, LLC, dba Reliant Pharmacy, Southbury, CT

• Referral Letter to the Connecticut Commission of Pharmacy Issued 3/25/2015 (PDF - 68KB)

Zions RX Formulations Services (see Rx Formulations), Mesa, AZ  


Contract Testing Laboratories:

Analytical Research Laboratories, Oklahoma City, OK (see ARL Biopharma, Inc.)

ARL Biopharma, Inc. dba Analytical Research Laboratories, Oklahoma City, OK

• 483 Issued 11/8/2012 (PDF - 382KB)

Boston Analytical, Inc., Salem, NH

• 483 Issued 11/9/2012 (PDF - 490KB) 

Dyna Labs, LLC, St. Louis, MO

• 483 Issued 11/13/2012 (PDF - 1MB)

Eagle Analytical Services, Houston, TX

• 483 Response Dated 7/9/2013 (PDF - 2.8MB)
• 483 Issued 6/17/2013 (PDF - 984KB) 

Front Range Laboratories, Inc., Loveland, CO

• CDER Statement: FDA Alerts Pharmacies to Concerns with Testing Conducted by Front Range Laboratories (8/21/2013)
• FDA Letter to Front Range Customers (PDF – 65KB)
• 483 Issued 8/30/2013 (PDF - 1.6MB)