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FDA CGMP Warning Letters in 2006
Published on:
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.)
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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
| 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
| 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 |
