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 November 30, 2010
| Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
|---|---|---|---|---|
| October 15, 2010 | Prime Time Seafood, Inc | Los Angeles District Office | Seafood HACCP/CGMP for Foods/Adulterated | June 27, 2011 |
| October 14, 2010 | Contract Pharmacal Corporation | New York District Office | CGMP for Finished Pharmaceuticals/Adulterated/Misbranded | April 18, 2012 |
| October 14, 2010 | Blum's Spring Lake Fisheries | Minneapolis District Office | Seafood HACCP/CGMP for Foods/Adulterated/Misbranded | July 29, 2011 |
| October 14, 2010 | Irish Acres Dairy LLC | Detroit District Office | Animals for Sale for Slaughter as Food/Adulterated | February 07, 2011 |
| October 13, 2010 | Bos Dairy LLC | Detroit District Office | Animals for Sale for Slaughter as Food/Adulterated | May 09, 2011 |
| October 12, 2010 | Longevity Plus, LLC | Los Angeles District Office | Unapproved New Drugs/Misbranded | Not Issued * |
| October 12, 2010 | Hormonal Health, LLC | Los Angeles District Office | Unapproved New Drugs/Misbranded | Not Issued * |
| October 12, 2010 | Dr. Rhonda Henry | San Francisco District Office | Unapproved New Drugs/Misbranded | Not Issued * |
| October 12, 2010 | Advanced Testing Laboratory Inc | Cincinnati District Office | CGMP for Finished Pharmaceuticals/Adulterated | September 26, 2011 |
| October 12, 2010 | Evenbetternow, LLC | Los Angeles District Office | Unapproved New Drugs/Misbranded | May 03, 2011 |
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