Inspections, Compliance, Enforcement, and Criminal Investigations
2000 Warning Letters
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Warning Letters for 2000
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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 |
|---|---|---|---|---|
| September 06, 2000 | Cape Atlantic Medical Inc. | New Jersey District Office | Medical Oxygen / CGMP | N/A * |
| September 06, 2000 | BCA Internaional Inc. | Florida District Office | Hema-Strip HIV-1/2 Test Kit/Lacks Investigational Device Exemption/Export Listing Violation | N/A * |
| September 06, 2000 | New Pacific Inc. | Center for Devices and Radiological Health | Laser Product Performance Standards/Laser Light Show/Electronic Product Radiation Control | N/A * |
| September 06, 2000 | Woman's Clinic | New Orleans District Office | Mammography Standards | N/A * |
| September 06, 2000 | International Diagnostic & Medical Supply Corporation | Florida District Office | Hema-Strip HIV-1/2 Test Kit/Lacks Investigational Device Exemption/Export Listing Violation | N/A * |
| September 06, 2000 | Jerome Stevens Pharmaceuticals Inc. | New York District Office | Digoxin Tablets/Good Manufacturing Practices for Finished Pharmaceuticals | N/A * |
| September 05, 2000 | Davis Dairy Farm | New England District Office | Food/Dairy Cow | N/A * |
| September 05, 2000 | Bolivar General Hospital | New Orleans District Office | Mammography Standards | N/A * |
| September 05, 2000 | Shands Jacksonville Medical Center | Florida District Office | Mammography Standards | N/A * |
| September 05, 2000 | Jonlly Fruits, Inc. | San Juan District Office | Labeling/Adulterated/Misbranded | N/A * |
| September 05, 2000 | Imaging Centers of Anaheim / Tan Tran M.D. Inc. | Los Angeles District Office | Mammography Standards | N/A * |
| September 05, 2000 | San Gennaro Foods Inc. | Seattle District Office | Polenta/Production Processing Controls Acidified Foods etc. | N/A * |
| September 01, 2000 | Diagnostic Medical Group of Southern California | Los Angeles District Office | Mammography Standards | N/A * |
| September 01, 2000 | DeLonghi S.p.A | Center for Devices and Radiological Health | Federal Performance Standard for Microwave Ovens | N/A * |
| September 01, 2000 | Slim Center | Florida District Office | Body Gel/Lacks "May Proceed Notice" or "Release Notice" | N/A * |
| September 01, 2000 | Viking Village Inc. | New Jersey District Office | Seafood Processing Regulations/HACCP | N/A * |
| August 31, 2000 | Pear Garden Produce | Los Angeles District Office | CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts | N/A * |
| August 31, 2000 | Consolidated Nutrition L.C. | San Juan District Office | Medicated Feeds | N/A * |
| August 31, 2000 | Orange Bean Sprouts | Los Angeles District Office | CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts | N/A * |
| August 31, 2000 | Monarch Seafoods Inc. | San Francisco District Office | Seafood Processing Regulations/HACCP | N/A * |
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