FDA CGMP Warning Letters in 2006 - Pharmaceutical Technology

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FDA CGMP Warning Letters in 2006


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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 Office
Total
Total Pharma
CGMP/ Finished  Pharma- ceuticals
CGMP/ Active Pharma-ceutical Ingredient
CGMP/ Biologicals
Pharmacy Compounding
CGMP/ Blood and Blood Components
CGMP/ Medical Device
Total
117
36
17
4
1
14
8
73
Atlanta District Office
5
2
1
 
 
1
 
3
Baltimore District Office
2
1
1
 
 
 
 
1
Chicago District Office
3
1
1
 
 
 
 
2
Cincinnati District Office
13
3
 
 
 
3
 
10
Dallas District Office
13
2
2
 
 
 
1
10
Denver District Office
3
2
 
1
 
1
 
1
Detroit District Office
5
1
 
 
 
1
 
4
Florida District Office
6
3
 
 
 
3
1
2
Kansas City District Office
4
1
1
 
 
 
2
1
Los Angeles District Office
10
0
 
 
 
 
2
8
Minneapolis District Office
7
2
1
1
 
 
2
3
New England District Office
4
2
1
 
 
1
 
2
New Jersey District Office
8
4
2
 
 
2
 
4
New Orleans District Office
6
2
2
 
 
 
 
4
New York District Office
2
0
 
 
 
 
 
2
Philadelphia District Office
3
1
 
 
 
1
 
2
San Francisco District Office
3
0
 
 
 
 
 
3
San Juan District Office
2
2
2
 
 
 
 
 
Seattle District Office
5
1
1
 
 
 
 
4
 
 
 
 
 
 
 
 
 
Office of Enforcement
1
1
 
 
1
 
 
 
Center/Devices and Radiological Health
7
0
 
 
 
 
 
7
Center/Drug Evaluation and Research
4
4
2
1
 
1
 
 
Center/Veterinary Medicine
1
1
 
1
 
 
 
 

 

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

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

pharmacy
compounding

http://www.fda.gov/foi/warning_letters/g5975d.htm
CCS Medical 8/9/2006 Florida District Office pharmacy compounding http://www.fda.gov/foi/warning_letters/g5963d.htm
Rotech Healthcare, Inc. 8/9/2006 Cincinnati District Office pharmacy compounding http://www.fda.gov/foi/warning_letters/g5964d.htm
CCS Medical 8/9/2006 Florida District Office pharmacy compounding http://www.fda.gov/foi/warning_letters/g5974d.htm
Pascal Company, Inc. 8/9/2006 Seattle District Office CGMP/finished pharmaceuticals http://www.fda.gov/foi/warning_letters/g5990d.htm
Pointe Scientific Inc. 8/11/2006 Detroit District Office CGMP/medical device http://www.fda.gov/foi/warning_letters/g5991d.htm
The Service Center 8/17/2006 Chicago District Office CGMP/finished pharmaceuticals http://www.fda.gov/foi/warning_letters/g5993d.htm
Command Medical Products 8/17/2006 Florida District Office CGMP/medical device http://www.fda.gov/foi/warning_letters/g6001d.htm
Chien Ti Enterprise Co., Ltd. 8/28/2006 Center/Devices and Radiological Health CGMP/medical device http://www.fda.gov/foi/warning_letters/g6004d.htm
LGS Technologies, LP 8/29/2006 Dallas District Office CGMP/medical device http://www.fda.gov/foi/warning_letters/g6009d.htm
Medtronic, Inc. 8/29/2006 Minneapolis District Office CGMP/medical device http://www.fda.gov/foi/warning_letters/g6010d.htm
Terumo Cardiovascular Systems 8/31/2006 Detroit District Office CGMP/medical device http://www.fda.gov/foi/warning_letters/g6011d.htm
Frye Health Systems, Inc. 8/31/2006 Dallas District Office CGMP/medical device http://www.fda.gov/foi/warning_letters/g6013d.htm
Biolase Technology, Inc. 9/5/2006 Los Angeles District Office CGMP/medical device http://www.fda.gov/foi/warning_letters/g6016d.htm
Smith Medical Critical Care, Inc. 9/5/2006 Cincinnati District Office CGMP/medical device http://www.fda.gov/foi/warning_letters/g6019d.htm
Hawkins, Inc. 9/8/2006 Minneapolis District Office CGMP/active pharmaceutical ingredient http://www.fda.gov/foi/warning_letters/g6022d.htm
Matheson Tri-Gas, Inc. 9/12/2006 Dallas District Office CGMP/finished pharmaceuticals http://www.fda.gov/foi/warning_letters/g6127d.htm
Matheson Tri-Gas, Inc. 9/12/2006 Dallas District Office CGMP/finished pharmaceuticals http://www.fda.gov/foi/warning_letters/g6096d.htm
Dialysis Services, Inc. 9/15/2006 New Orleans District Office CGMP/medical device http://www.fda.gov/foi/warning_letters/g6058d.htm
Thermoplastic Comfort Systems, Inc. 9/21/2006 Los Angeles District Office CGMP/medical device http://www.fda.gov/foi/warning_letters/g6041d.htm
Berkline, LLC 9/21/2006 New Orleans District Office CGMP/medical device http://www.fda.gov/foi/warning_letters/g6033d.htm
Radiometer Medical Aps 9/27/2006 Center/Devices and Radiological Health CGMP/medical device http://www.fda.gov/foi/warning_letters/g6156d.htm
EP Medsystems 9/27/2006 New Jersey District Office CGMP/medical device http://www.fda.gov/foi/warning_letters/g6097d.htm
Banner Pharmacaps, Inc. 9/28/2006 Atlanta District Office CGMP/finished pharmaceuticals http://www.fda.gov/foi/warning_letters/g6061d.htm
International Brachytherapy s.a. 10/11/2006 Center/Devices and Radiological Health CGMP/medical device http://www.fda.gov/foi/warning_letters/g6054d.htm
Radiometer America, Inc. 10/12/2006 Cincinnati District Office CGMP/medical device http://www.fda.gov/foi/warning_letters/g6087d.htm
Patterson Technology Center, Inc. 10/24/2006 Chicago District Office CGMP/medical device http://www.fda.gov/foi/warning_letters/g6102d.htm
Memorial Medical Center 10/24/2006 Minneapolis District Office CGMP/blood and blood components http://www.fda.gov/foi/warning_letters/g6101d.htm
Pharmacy Creations 10/31/2006 New Jersey District Office pharmacy compounding http://www.fda.gov/foi/warning_letters/g6168d.htm
Wedgewood Village Pharmacy 10/31/2006 New Jersey District Office pharmacy compounding http://www.fda.gov/foi/warning_letters/g6167d.htm
Bausch & Lomb 10/31/2006 Atlanta District Office CGMP/medical device http://www.fda.gov/foi/warning_letters/g6107d.htm
Dr. Steven K. Sue, D.D.S., M.S., Inc. 10/31/2006 San Francisco District Office CGMP/medical device http://www.fda.gov/foi/warning_letters/g6108d.htm
M & S Acquisition 11/1/2006 Cincinnati District Office CGMP/medical device http://www.fda.gov/foi/warning_letters/g6115d.htm
Perkins Electronics Company 11/2/2006 Dallas District Office CGMP/medical device http://www.fda.gov/foi/warning_letters/g6116d.htm
Gyrus ENT, LLC 11/13/2006 New Orleans District Office CGMP/medical device http://www.fda.gov/foi/warning_letters/g6122d.htm
Trionix Research Laboratory, Inc. 11/21/2006 Cincinnati District Office CGMP/medical device http://www.fda.gov/foi/warning_letters/g6139d.htm
Dupaco, Inc. 11/21/2006 Los Angeles District Office CGMP/medical device http://www.fda.gov/foi/warning_letters/g6148d.htm
Health Dimensions, Inc. 11/27/2006 Detroit District Office pharmacy compounding http://www.fda.gov/foi/warning_letters/g6150d.htm
Skytron 11/29/2006 Detroit District Office CGMP/medical device http://www.fda.gov/foi/warning_letters/g6153d.htm
Spoonamore Drug Co., Inc. 12/1/2006 Cincinnati District Office pharmacy compounding http://www.fda.gov/foi/warning_letters/g6154d.htm
Customs Scripts Pharmacy 12/4/2006 Florida District Office pharmacy compounding http://www.fda.gov/foi/warning_letters/g6145d.htm
New England Compounding Center 12/4/2006 New England District Office pharmacy compounding http://www.fda.gov/foi/warning_letters/g6147d.htm
Triangle Compounding Pharmacy 12/4/2006 Atlanta District Office pharmacy compounding http://www.fda.gov/foi/warning_letters/g6144d.htm
Hal's Compounding Pharmacy, Inc. 12/4/2006 Center/Drug Evaluation and Research pharmacy compounding http://www.fda.gov/foi/warning_letters/g6146d.htm
University Pharmacy 12/4/2006 Denver District Office pharmacy compounding http://www.fda.gov/foi/warning_letters/g6143d.htm
Nasiff Associates, Inc. 12/8/2006 New York District Office CGMP/medical device http://www.fda.gov/foi/warning_letters/g6178d.htm
MRL Inc. 12/8/2006 Chicago District Office CGMP/medical device http://www.fda.gov/foi/warning_letters/g6173d.htm
Quick-Fill Mobile Oxygen, Inc. 12/8/2006 New Orleans District Office CGMP/finished pharmaceuticals http://www.fda.gov/foi/warning_letters/g6172d.htm

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