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U.S. Department of Health and Human Services

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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
August 12, 1999 Sushi On A Roll Inc. [ARCHIVED] Los Angeles District Office Seafood Processing Regulations/HACCP N/A *
August 12, 1999 Virginia Commonwealth University [ARCHIVED] Center for Devices and Radiological Health IRB (Institutional Review Board) N/A *
August 12, 1999 Thoratec Laboratories Corporation [ARCHIVED] Center for Devices and Radiological Health Ventricular Assist Device (VAD)/Promotional Claims N/A *
August 11, 1999 Rapini Inc. dba Pari-Pai Ko [ARCHIVED] New York District Office Good Manufacturing Practices Deviations N/A *
August 11, 1999 Denton Hospital Inc. [ARCHIVED] Dallas District Office Mammography Standards N/A *
August 11, 1999 HK Surgical Inc. [ARCHIVED] Center for Devices and Radiological Health Devices/Microcannulas & Aspirators N/A *
August 11, 1999 Shepherd Eye Center Institutional Review Board [ARCHIVED] Center for Devices and Radiological Health IRB (Institutional Review Board) N/A *
August 11, 1999 Total Respiratory Services and Medical [ARCHIVED] Chicago District Office Medical Oxygen / CGMP N/A *
August 10, 1999 Kaweah Delta District Hospital [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting Regulation/Fetal Vaccuum Extractor N/A *
August 10, 1999 Bio-Pharm Inc. [ARCHIVED] Philadelphia District Office Good Manufacturing Practices/Drug Products Manufactured N/A *
August 06, 1999 Phillips Gulf Corporation [ARCHIVED] Florida District Office Labeling/ARH-RX Oral Capsules N/A *
August 06, 1999 Vitalograph (ireland) Ltd. [ARCHIVED] Center for Devices and Radiological Health Quality System Regulation/Spirometers & Peak Flow Meters N/A *
August 06, 1999 Drager Medizintechnik GmbH [ARCHIVED] Center for Devices and Radiological Health Quality System Regulation/Anesthesia Intensive Care Ventilators Incubators & Other Medical Devices N/A *
August 06, 1999 Mueller Sports Medicine Inc. [ARCHIVED] Minneapolis District Office CGMP Deviations N/A *
August 06, 1999 Unique Health Solutions [ARCHIVED] New York District Office Labeling/MSM Eye & Ear Drops N/A *
August 06, 1999 Moossa Abdool R. M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
August 06, 1999 Bernard A. te Velde Sr. Dairy #2 [ARCHIVED] San Francisco District Office Food/Cattle N/A *
August 05, 1999 Primus Sterilizer Co. Inc. [ARCHIVED] Kansas City District Office Quality System Rgulations/Clinical Steam Sterilizers N/A *
August 05, 1999 RCS Home Medical Equipment Inc. [ARCHIVED] Nashville District Office Medical Oxygen N/A *
August 05, 1999 Roundman's Smoke House & Wholesale Meats [ARCHIVED] San Francisco District Office Seafood Processing Regulations/HACCP N/A *



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ICECI Warning Letters

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