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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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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

 
Letter Issue Date Company Name Issuing Office Subject Close Out Date
October 29, 1999 Sibley Memorial Hospital Baltimore District Office Blood Products/Standard Operating Procedures (SOP) N/A *
October 29, 1999 Catalytica Inc. Atlanta District Office Active Pharmaceutical Ingredient N/A *
October 28, 1999 Ancar Import Corporation Florida District Office Seafood Processing Regulations/HACCP N/A *
October 28, 1999 Palmer Farms Inc. Minneapolis District Office Food/Cattle N/A *
October 27, 1999 Rand Robert W. Ph.D. M.D. Center for Biologics Evaluation and Research Clinical Investigator N/A *
October 27, 1999 George M. Takushi M.D. Inc. San Francisco District Office Mammography Standards N/A *
October 27, 1999 Emily's Seafood New Orleans District Office Seafood Processing Regulations/HACCP N/A *
October 27, 1999 Little Falls Hospital New York District Office Mammography Standards N/A *
October 26, 1999 Coppell Diagnostic Imaging Center Dallas District Office Mammography Standards N/A *
October 26, 1999 Alegent Health Milands community Hospital Dallas District Office Mammography Standards N/A *
October 26, 1999 St. Joseph Hospital - Creighton Radiologists Dallas District Office Mammography Standards N/A *
October 26, 1999 St. Paul Breast Center Dallas District Office Mammography Standards N/A *
October 25, 1999 Accutech Orthodontic Laboratory Center for Devices and Radiological Health Sleep Apnea Goldilocks (SAGA)/Marketing without PreMarket Notification Submission (510K) N/A *
October 25, 1999 Rapp's Dairy Baltimore District Office Food/Cattle N/A *
October 22, 1999 Boston Medical Center New England District Office Mammography Standards N/A *
October 22, 1999 Kaiser Permanente Atlanta District Office Mammography Standards N/A *
October 22, 1999 Community General Hospital Atlanta District Office Mammography Standards N/A *
October 22, 1999 Matrix Biokinetics Inc. San Francisco District Office Quality System Requirement N/A *
October 22, 1999 Bridgewater Goddard Park Medical Associates Inc. New England District Office Mammography Standards N/A *
October 22, 1999 4nRx/New Zealand Center for Drug Evaluation and Research Drug Marketing/Unapproved Prescription Drugs N/A *



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ICECI Warning Letters

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