Inspections, Compliance, Enforcement, and Criminal Investigations
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2010 Warning Letters
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Warning Letters issued in 2010
* 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 January 26, 2010
| Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
|---|---|---|---|---|
| January 19, 2010 | SweetSommer Water Bottling Company, LLC. | Baltimore District Office | Processing and Bottling of Bottled Drinking Water/Adulterated | Not Issued * |
| January 19, 2010 | Crown Health Care Laundry Services, Inc. | New Orleans District Office | CGMP/QSR/Adulterated/Manufacture/Packing/Storage/Installation | Not Issued * |
| January 19, 2010 | Sun Hang Bean Sprout Inc | Detroit District Office | CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Misbranded/Insanitary Conditions | Not Issued * |
| January 19, 2010 | Cayman Chemical Company | Center for Drug Evaluation and Research | Clinical Investigator (Sponsor) | Not Issued * |
| January 15, 2010 | Cybernet Systems Corp. | Detroit District Office | CGMP/QS/Adulterated/Misbranded | Not Issued * |
| January 15, 2010 | McNeil Consumer and Specialty Pharmaceuticals | San Juan District Office | CGMP Regulations for Finished Pharmaceuticals/Adulterated | Not Issued * |
| January 15, 2010 | Baxter Biosciences | Center for Biologics Evaluation and Research | CGMP Deviations | March 22, 2010 |
| January 14, 2010 | Premium Dental, LLC | New Jersey District Office | CGMP/QSR/Medical Devices/Adulterated | February 04, 2011 |
| January 14, 2010 | Sunrise Pharmaceutical, Inc. | New Jersey District Office | CGMP for Finished Pharmaceuticals/Adulterated/Mi sbranded | December 20, 2011 |
| January 14, 2010 | Boonesboro Animal Clinic Corporation | Cincinnati District Office | Illegal Drug Residue | December 06, 2011 |
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