1999 Warning Letters

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Warning Letters for 1999

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* Not issued: A close-out letter may issue when, based on FDA’s evaluation, the firm has taken corrective action to address the violations contained in the Warning Letter. This procedure applies to Warning Letters issued on or after September 1, 2009.

* N/A: Not applicable, the Warning Letter was issued prior to September 1, 2009.

Read more about warning and close-out letters

 

Posted on May 26, 2009

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
December 30, 1999	Universal Packaging Systems Inc.	Los Angeles District Office	CGMP/Finished Pharmaceuticals	N/A *
December 30, 1999	Raphah Inc.	New Jersey District Office	Food Labeling	N/A *
December 30, 1999	Breger Vision	Center for Devices and Radiological Health	Contact Lenses/Lacks Premarket Approval/Misbranded	N/A *
December 30, 1999	Medical Developmental Research Inc.	Center for Devices and Radiological Health	Sponsor/Monitor/Contract Research Organization	N/A *
December 29, 1999	N. V. N. Inc.	New Jersey District Office	Seafood Processing Regulations/HACCP	N/A *
December 27, 1999	Paynesville Area Health Care System	Minneapolis District Office	Mammography Standards	N/A *
December 27, 1999	TUCO Innovations Inc.	Center for Devices and Radiological Health	Laser Therapy Devices	N/A *
December 27, 1999	ConAgra Inc.	Kansas City District Office	Medicated Feeds/CGMP	N/A *
December 23, 1999	Fantis Foods Inc.	New Jersey District Office	Seafood Processing Regulations/HACCP	N/A *
December 23, 1999	Alliance Medical Corporation	Florida District Office	Quality System Regulation/Medical Devices Processing	N/A *
December 23, 1999	Genetics Institute	Center for Biologics Evaluation and Research	CGMP Deviations	N/A *
December 23, 1999	Diasorin s.r.l.	Center for Biologics Evaluation and Research	Quality System Regulation	N/A *
December 23, 1999	Tower Rubber Industries Sdn Bhd	Center for Devices and Radiological Health	Quality System Regulation/Patient Examination Gloves	N/A *
December 23, 1999	Miller's Homecare Services	New Jersey District Office	Oxygen Repackaging Facility	N/A *
December 22, 1999	Amelia Springs Water Inc.	Baltimore District Office	Bottle Water Operation	N/A *
December 22, 1999	Entrees Inc.	Seattle District Office	Seafood Processing Regulations/HACCP	N/A *
December 22, 1999	Associates of Cape Cod Inc.	Center for Biologics Evaluation and Research	Quality System Regulation/Biologics Listing etc.	N/A *
December 22, 1999	Coulston Foundation	Center for Drug Evaluation and Research	GLP (Good Laboratory Practices)	N/A *
December 22, 1999	Salmolux Inc.	Seattle District Office	Seafood Processing Regulations/HACCP	N/A *
December 22, 1999	D and M Dairy	San Francisco District Office	Food/Cattle	N/A *
December 21, 1999	Mountain Products Inc.	New York District Office	Seafood Processing Regulations/HACCP	N/A *
December 21, 1999	Fabrica de Flanes Acevedo	San Juan District Office	Food Labeling	N/A *
December 21, 1999	Progressive Dairy #1	San Francisco District Office	Food/Cattle	N/A *
December 21, 1999	Northwest Airlines	New York District Office	PHS Act & Control of Communicable Diseases & Interstate Conveyance Sanitation Violations	N/A *
December 21, 1999	Emapacadora La Montana, Inc.	San Juan District Office	GMP for Deviations/Adulterated/Misbran ded	N/A *
December 20, 1999	Shared Medical Technology	Minneapolis District Office	Mammography Standards	N/A *
December 20, 1999	H. B. Gordon manufacturing Co. Inc.	Los Angeles District Office	Finished Pharmaceuticals	N/A *
December 20, 1999	Staten Island University Hospital	New York District Office	Blood & Blood Components	N/A *
December 20, 1999	Capt. Vince Inc.	New England District Office	Seafood Processing Regulations/HACCP	N/A *
December 20, 1999	Westfield Memorial Hospital	Buffalo District Office	Mammography Standards	N/A *
December 20, 1999	Danmar Product Inc.	Center for Devices and Radiological Health	Medical Devices / Premarket Approval Application [PMA]	N/A *
December 20, 1999	Bassett Healthcare	New York District Office	Mammography Standards	N/A *
December 20, 1999	Thatcher Company	Denver District Office	Active Pharmaceutical Ingredient	N/A *
December 20, 1999	Cooksey James R.	Cincinnati District Office	Food/Cattle	N/A *
December 20, 1999	Disetronic Medical Systems Inc.	Minneapolis District Office	Quality System Regulation/Infusion Pumps	N/A *
December 17, 1999	Hoffmann-LaRoche Inc.	New Jersey District Office	CGMP/Finished Pharmaceuticals	N/A *
December 17, 1999	Health Care Solutions Inc.	Detroit District Office	Medical Oxygen / CGMP	N/A *
December 17, 1999	Ortho Clinical Diagnostics Americas	Los Angeles District Office	Laser Therapy Device/Lacks Premarket Approval/Misbranding/Mislabeling	N/A *
December 17, 1999	Baton Rouge Clinic AMC	New Orleans District Office	Mammography Standards	N/A *
December 17, 1999	Thames Pharmacal Co. Inc.	New York District Office	Finished Pharmaceuticals	N/A *
December 17, 1999	Rynsburger Dairy	San Francisco District Office	Food/Cattle	N/A *
December 16, 1999	Amanda Animal Hospital	Cincinnati District Office	Food/Cattle	N/A *
December 16, 1999	Gourmet Award Foods SE	Florida District Office	Food/Hearts of Palm	N/A *
December 15, 1999	Basha Diagnostics P.C.	Detroit District Office	Mammography Standards	N/A *
December 15, 1999	International Sterilization Laboratory Corporation	Florida District Office	Quality System Regulation/Medical Devices Contract Sterilization	N/A *
December 14, 1999	Radiology & Imagaing Inc.	New England District Office	Mammography Standards	N/A *
December 14, 1999	St. Luke's Hospital	Minneapolis District Office	Mammography Standards	N/A *
December 14, 1999	Bladen County Hospital	Atlanta District Office	Mammography Standards	N/A *
December 14, 1999	Grand Strand Regional Medical Center	Atlanta District Office	Mammography Standards	N/A *
December 14, 1999	American Eagle Airlines Inc.	Minneapolis District Office	Control of Communicable Disease and Interstate Conveyance Sanitation	N/A *

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