FDA CGMP Warning Letters in 2006

December 28, 2006
Pharmaceutical Technology Editors
ePT--the Electronic Newsletter of Pharmaceutical Technology

Pharmaceuticals current good manufacturing practice (CGMP) violations accounted for just 36 of the 441 Warning Letters issued by the US Food and Drug Administration in 2006.

 

Rockville, MD (Dec. 28)-Pharmaceuticals current good manufacturing practice (CGMP) violations accounted for just 36 of the 441 Warning Letters issued by the US Food and Drug Administration (www.fda.gov) in 2006.

These included 17 CGMP warnings for drug products (including medical gases), four for active pharmaceutical ingredients, one for a biological, and 14 warnings to compounding pharmacies (reflecting the agency's continuing conflict with compounders) (see Table I).

Medical device operations, by comparison, received 73 official CGMP warnings during the year, and blood and blood-product producers were warned 8 times for CGMP shortcomings. (FDA issued the great majority of 2006's Warning Letters for false and misleading advertising, with about 100 citations, and a variety of food-processing problems, ranging from illegal drug residues in milk to errors in processing seafood.)

Nineteen FDA district offices issued 30 of the 36 pharmaceutical CGMP warnings (and 104 of the 117 overall medical CGMP letter). The New Jersey District Office issued four pharmaceutical CGMP warnings, more than any other office (though the Center for Drug Evaluation and Research in Rockville also issued four Warnings). The Cincinnati and Florida District Offices issued three citations each-all to compounding pharmacies.

See Table II for a chronological listing of pharmaceutical and device CGMP warning letters issued over the past year.

Table I: Number of US Food and Drug Administration 2006 Current Good Manufacturing Practices (CGMPs) Warning Letters

Issuing OfficeTotalTotal PharmaCGMP/ Finished  Pharma- ceuticalsCGMP/ Active Pharma-ceutical IngredientCGMP/ BiologicalsPharmacy CompoundingCGMP/ Blood and Blood ComponentsCGMP/ Medical Device
Total11736174114873
Atlanta District Office521  1 3
Baltimore District Office211    1
Chicago District Office311    2
Cincinnati District Office133   3 10
Dallas District Office1322   110
Denver District Office32 1 1 1
Detroit District Office51   1 4
Florida District Office63   312
Kansas City District Office411   21
Los Angeles District Office100    28
Minneapolis District Office7211  23
New England District Office421  1 2
New Jersey District Office842  2 4
New Orleans District Office622    4
New York District Office20     2
Philadelphia District Office31   1 2
San Francisco District Office30     3
San Juan District Office222     
Seattle District Office511    4
         
Office of Enforcement11  1   
Center/Devices and Radiological Health70     7
Center/Drug Evaluation and Research4421 1  
Center/Veterinary Medicine11 1    

 

Table II. US Food and Drug Administration 2006 Current Good Manufacturing Practices (CGMPs) Warning Letters

Theken Spine LLC1/3/2006Cincinnati District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g5681d.htm
Haemacure Corporation1/5/2006Florida District OfficeCGMP/medical devicemedical devicehttp://www.fda.gov/foi/warning_letters/g5692d.htm
Gambro Dasco S.p.a.1/5/2006Center/Devices and Radiological HealthCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g5687d.htm
CareFore Medical Incorporated1/10/2006Kansas City District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g5690d.htm
National Genetics Institute1/17/2006Los Angeles District OfficeCGMP/blood and blood componentshttp://www.fda.gov/foi/warning_letters/g5699d.htm
K & D Produce, Inc.1/18/2006Florida District OfficeCGMP/blood and blood componentshttp://www.fda.gov/foi/warning_letters/g5722d.htm
International BioResources, LLC1/20/2006Minneapolis District OfficeCGMP/blood and blood componentshttp://www.fda.gov/foi/warning_letters/g5698d.htm
ZLB Behring1/24/2006Kansas City District OfficeCGMP/blood and blood componentshttp://www.fda.gov/foi/warning_letters/g5701d.htm
Boston Scientific Corporation1/25/2006New England District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g5691d.htm
GAMBRO AB2/13/2006Denver District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g5718d.htm
Southern Meds Joint Venture, LLC2/15/2006New Orleans District OfficeCGMP/finished pharmaceuticalshttp://www.fda.gov/foi/warning_letters/g5719d.htm
Oculus Optikgerate GmbH2/21/2006Center/Devices and Radiological HealthCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g5733d.htm
Wockhardt Ltd.2/21/2006Center/Drug Evaluation and ResearchCGMP/active pharmaceutical ingredienthttp://www.fda.gov/foi/warning_letters/g5793d.htm
MicroSurgical Technologies, Inc.3/1/2006Seattle District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g5749d.htm
AJP Scientific, Inc.3/2/2006New Jersey District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g5808d.htm
Community Blood Center of Greater Kansas City3/9/2006Kansas City District OfficeCGMP/blood and blood componentshttp://www.fda.gov/foi/warning_letters/g5892d.htm
General Atomics3/13/2006Los Angeles District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g5780d.htm
B. Braun Medical Inc.3/15/2006Philadelphia District Officepharmacy compoundinghttp://www.fda.gov/foi/warning_letters/g5817d.htm
FRM Chemical, Inc.3/16/2006Kansas City District OfficeCGMP/finished pharmaceuticalshttp://www.fda.gov/foi/warning_letters/g5761d.htm
Agile Radiological Technologies, Inc.3/17/2006Cincinnati District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g5783d.htm
In Vivo Metric Systems Corporation3/17/2006San Francisco District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g5762d.htm
EEMSO, Inc.3/30/2006Dallas District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g5791d.htm
EM Innovations, Inc.4/1/2006Cincinnati District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g5794d.htm
Orthohelix Surgical Designs, Inc.4/7/2006Cincinnati District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g5797d.htm
Ferno-Washington, Inc.4/7/2006Cincinnati District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g5804d.htm
Cody Laboratories, Inc.4/7/2006Denver District OfficeCGMP active pharmaceutical ingredienthttp://www.fda.gov/foi/warning_letters/g5798d.htm
Neurotone Systems, Inc.4/10/2006Dallas District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g5799d.htm
Resonance Technology, Inc.4/13/2006Los Angeles District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g5806d.htm
Advanced Imaging Research, Inc.4/20/2006Cincinnati District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g5828d.htm
TEFTEC Corporation4/24/2006Dallas District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g5815d.htm
Carolina Liquid Chemisties Corporation4/25/2006Los Angeles District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g5824d.htm
Minntech Corporation4/25/2006Minneapolis District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g5831d.htm
HemaCare Corporation4/27/2006Los Angeles District OfficeCGMP/blood and blood componentshttp://www.fda.gov/foi/warning_letters/g5833d.htm
Pliva Croatia Ltd.4/28/2006Center/Drug Evaluation and ResearchCGMP/finished pharmaceuticalshttp://www.fda.gov/foi/warning_letters/g5825d.htm
Tri-State Hospital Supply Corporation5/3/2006Atlanta District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g5865d.htm
Aquarium Products5/3/2006Baltimore District OfficeCGMP/finished pharmaceuticalshttp://www.fda.gov/foi/warning_letters/g5874d.htm
Wyeth Pharmaceuticals Company5/8/2006San Juan District OfficeCGMP/finished pharmaceuticalshttp://www.fda.gov/foi/warning_letters/g5851d.htm
Therics, LLC5/15/2006New Jersey District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g5852d.htm
ESKA Implants GmbH & Co.5/16/2006Center/Devices and Radiological HealthCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g5882d.htm
Tek Marketing, Inc.5/22/2006Philadelphia District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g5893d.htm
Westone Laboratories, Inc.5/22/2006Seattle District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g5856d.htm
Quality Aspirators, Inc.5/23/2006Dallas District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g5860d.htm
Smiths Group Plc.5/24/2006Center/Devices and Radiological HealthCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g5862d.htm
Restorative Health Services, Inc.5/30/2006New Orleans District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g5864d.htm
Neil Laboratories Inc.5/31/2006New Jersey District OfficeCGMP/finished pharmaceuticalshttp://www.fda.gov/foi/warning_letters/g5878d.htm
Dux Industries Inc.6/1/2006Los Angeles District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g5888d.htm
Visionary Contact Lens, Inc.6/1/2006Los Angeles District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g5879d.htm
Electric Mobility Corporation6/1/2006New Jersey District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g5887d.htm
Tri-State Hospital Supply Corporation6/2/2006Detroit District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g5871d.htm
Gaymar Industries, Inc.6/8/2006New York District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g5895d.htm
Vapotherm, Inc.6/12/2006Baltimore District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g5890d.htm
Ranbaxy Laboratories Limited6/15/2006Center/Drug Evaluation and ResearchCGMP/finished pharmaceuticalshttp://www.fda.gov/foi/warning_letters/g5897d.htm
Watson Laboratories Caribe, Inc.6/19/2006San Juan District OfficeCGMP/finished pharmaceuticalshttp://www.fda.gov/foi/warning_letters/g5918d.htm
International BioResources LLC6/22/2006Dallas District OfficeCGMP/blood and blood componentshttp://www.fda.gov/foi/warning_letters/g5902d.htm
Guilin Pharmaceutical Corporation, Limited6/23/2006Center/Veterinary MedicineCGMP active pharmaceutical ingredienthttp://www.fda.gov/foi/warning_letters/g5898d.htm
Sanofi Pasteur6/30/2006Office of EnforcementCGMP/biologicalshttp://www.fda.gov/foi/warning_letters/g5899d.html
Pro Trainers Choice Company, Inc.7/3/2006Seattle District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g5933d.htm
International Biophysics Corporation7/10/2006Dallas District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g5937d.htm
Care Products Inc.7/10/2006Dallas District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g5939d.htm
Concord Laboratories, Inc.7/11/2006New Jersey District OfficeCGMP/finished pharmaceuticalshttp://www.fda.gov/foi/warning_letters/g5973d.htm
Cardiac Science Corporation7/11/2006Minneapolis District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g5947d.htm
Ultrasonic Services, Inc.7/17/2006Dallas District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g5941d.htm
Teleflex Inc.7/20/2006Atlanta District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g5966d.htm
Medisurg Research & Management Corporation7/20/2006Philadelphia District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g5985d.htm
Sheffield Laboratories, Div. of Faria Limited, LLC7/24/2006New England District OfficeCGMP/finished pharmaceuticalshttp://www.fda.gov/foi/warning_letters/g5960d.htm
Safeway Industries7/27/2006Minneapolis District OfficeCGMP/finished pharmaceuticalshttp://www.fda.gov/foi/warning_letters/g5967d.htm
BioGenex Laboratories7/27/2006San Francisco District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g5961d.htm
Wallach Surgical Devices, Inc.8/3/2006New England District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g5999d.htm
Sonotech, Incorporated8/8/2006Seattle District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g5988d.htm
Rotech Healthcare, Inc8/9/2006Cincinnati District Office

pharmacy
compounding

CCS Medical8/9/2006Florida District Officepharmacy compoundinghttp://www.fda.gov/foi/warning_letters/g5963d.htm
Rotech Healthcare, Inc.8/9/2006Cincinnati District Officepharmacy compoundinghttp://www.fda.gov/foi/warning_letters/g5964d.htm
CCS Medical8/9/2006Florida District Officepharmacy compoundinghttp://www.fda.gov/foi/warning_letters/g5974d.htm
Pascal Company, Inc.8/9/2006Seattle District OfficeCGMP/finished pharmaceuticalshttp://www.fda.gov/foi/warning_letters/g5990d.htm
Pointe Scientific Inc.8/11/2006Detroit District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g5991d.htm
The Service Center8/17/2006Chicago District OfficeCGMP/finished pharmaceuticalshttp://www.fda.gov/foi/warning_letters/g5993d.htm
Command Medical Products8/17/2006Florida District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g6001d.htm
Chien Ti Enterprise Co., Ltd.8/28/2006Center/Devices and Radiological HealthCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g6004d.htm
LGS Technologies, LP8/29/2006Dallas District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g6009d.htm
Medtronic, Inc.8/29/2006Minneapolis District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g6010d.htm
Terumo Cardiovascular Systems8/31/2006Detroit District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g6011d.htm
Frye Health Systems, Inc.8/31/2006Dallas District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g6013d.htm
Biolase Technology, Inc.9/5/2006Los Angeles District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g6016d.htm
Smith Medical Critical Care, Inc.9/5/2006Cincinnati District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g6019d.htm
Hawkins, Inc.9/8/2006Minneapolis District OfficeCGMP/active pharmaceutical ingredienthttp://www.fda.gov/foi/warning_letters/g6022d.htm
Matheson Tri-Gas, Inc.9/12/2006Dallas District OfficeCGMP/finished pharmaceuticalshttp://www.fda.gov/foi/warning_letters/g6127d.htm
Matheson Tri-Gas, Inc.9/12/2006Dallas District OfficeCGMP/finished pharmaceuticalshttp://www.fda.gov/foi/warning_letters/g6096d.htm
Dialysis Services, Inc.9/15/2006New Orleans District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g6058d.htm
Thermoplastic Comfort Systems, Inc.9/21/2006Los Angeles District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g6041d.htm
Berkline, LLC9/21/2006New Orleans District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g6033d.htm
Radiometer Medical Aps9/27/2006Center/Devices and Radiological HealthCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g6156d.htm
EP Medsystems9/27/2006New Jersey District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g6097d.htm
Banner Pharmacaps, Inc.9/28/2006Atlanta District OfficeCGMP/finished pharmaceuticalshttp://www.fda.gov/foi/warning_letters/g6061d.htm
International Brachytherapy s.a.10/11/2006Center/Devices and Radiological HealthCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g6054d.htm
Radiometer America, Inc.10/12/2006Cincinnati District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g6087d.htm
Patterson Technology Center, Inc.10/24/2006Chicago District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g6102d.htm
Memorial Medical Center10/24/2006Minneapolis District OfficeCGMP/blood and blood componentshttp://www.fda.gov/foi/warning_letters/g6101d.htm
Pharmacy Creations10/31/2006New Jersey District Officepharmacy compoundinghttp://www.fda.gov/foi/warning_letters/g6168d.htm
Wedgewood Village Pharmacy10/31/2006New Jersey District Officepharmacy compoundinghttp://www.fda.gov/foi/warning_letters/g6167d.htm
Bausch & Lomb10/31/2006Atlanta District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g6107d.htm
Dr. Steven K. Sue, D.D.S., M.S., Inc.10/31/2006San Francisco District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g6108d.htm
M & S Acquisition11/1/2006Cincinnati District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g6115d.htm
Perkins Electronics Company11/2/2006Dallas District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g6116d.htm
Gyrus ENT, LLC11/13/2006New Orleans District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g6122d.htm
Trionix Research Laboratory, Inc.11/21/2006Cincinnati District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g6139d.htm
Dupaco, Inc.11/21/2006Los Angeles District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g6148d.htm
Health Dimensions, Inc.11/27/2006Detroit District Officepharmacy compoundinghttp://www.fda.gov/foi/warning_letters/g6150d.htm
Skytron11/29/2006Detroit District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g6153d.htm
Spoonamore Drug Co., Inc.12/1/2006Cincinnati District Officepharmacy compoundinghttp://www.fda.gov/foi/warning_letters/g6154d.htm
Customs Scripts Pharmacy12/4/2006Florida District Officepharmacy compoundinghttp://www.fda.gov/foi/warning_letters/g6145d.htm
New England Compounding Center12/4/2006New England District Officepharmacy compoundinghttp://www.fda.gov/foi/warning_letters/g6147d.htm
Triangle Compounding Pharmacy12/4/2006Atlanta District Officepharmacy compoundinghttp://www.fda.gov/foi/warning_letters/g6144d.htm
Hal's Compounding Pharmacy, Inc.12/4/2006Center/Drug Evaluation and Researchpharmacy compoundinghttp://www.fda.gov/foi/warning_letters/g6146d.htm
University Pharmacy12/4/2006Denver District Officepharmacy compoundinghttp://www.fda.gov/foi/warning_letters/g6143d.htm
Nasiff Associates, Inc.12/8/2006New York District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g6178d.htm
MRL Inc.12/8/2006Chicago District OfficeCGMP/medical devicehttp://www.fda.gov/foi/warning_letters/g6173d.htm
Quick-Fill Mobile Oxygen, Inc.12/8/2006New Orleans District OfficeCGMP/finished pharmaceuticalshttp://www.fda.gov/foi/warning_letters/g6172d.htm