Inspections, Compliance, Enforcement, and Criminal Investigations
2001 Warning Letters
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Warning Letters for 2001
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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 July 23, 2009
| Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
|---|---|---|---|---|
| October 19, 2001 | Midwest Medical Holdings, LLC | Minneapolis District Office | Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated | N/A * |
| October 18, 2001 | Franco Fish Products, Inc. | Seattle District Office | Seafood HACCP | N/A * |
| October 18, 2001 | Borgess at Woodbridge Hills | Detroit District Office | Mammography Quality Standards | N/A * |
| October 18, 2001 | Romanucci Enterprises, Inc. | Chicago District Office | Insanitary Conditions/Adulterated | N/A * |
| October 18, 2001 | Wells Johnson Company | Los Angeles District Office | Quality System Regulation | N/A * |
| October 18, 2001 | Anthony Dinitto | Buffalo District Office | Illegal Drug Tissue Residue/Adulterated | N/A * |
| October 18, 2001 | Surgical Instruments Service & Savings, Inc. | Atlanta District Office | Quality System Regulation for Medical Devices/Adulterated | N/A * |
| October 18, 2001 | Franco Fish Products, Inc. | Seattle District Office | Seafood HACCP | N/A * |
| October 18, 2001 | Capital Fleet, Inc. | New Orleans District Office | Interstate Conveyance Sanitation Regulations | N/A * |
| October 17, 2001 | H & M Seafood | New Orleans District Office | Current Good Manufacturing Pratice Requirements for Foods/Seafood HACCP | N/A * |
| October 17, 2001 | Kham Seafood Company | New Orleans District Office | Current Good Manufacturing Pratice Requirements for Foods/Seafood HACCP | N/A * |
| October 17, 2001 | Sorenson Development, Inc. | Denver District Office | Quality System Regulation/Good Manufacturing Practice for Medical Devices/Adulterated | N/A * |
| October 17, 2001 | Mississippi Food Service, Inc. | New Orleans District Office | Seafood HACCP | N/A * |
| October 17, 2001 | Pet Magic, Inc. | Detroit District Office | Pig Ears Dog Treats/Lacks "May Proceed" or "Release Notice" | N/A * |
| October 17, 2001 | Healthcare Partners Medical Group | Los Angeles District Office | Mammography Quality Standards | N/A * |
| October 17, 2001 | Person & Covey | Los Angeles District Office | Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated | N/A * |
| October 16, 2001 | E.M. Parker | Center for Devices and Radiological Health | Performance Standard for Diagnostic X-ray Equipment | N/A * |
| October 16, 2001 | Omni Nutraceuticals, Inc. | Center for Drug Evaluation and Research | Labeling/Unapproved New Drug/Misbranded | N/A * |
| October 16, 2001 | Ramco Laboratories, Inc. | Dallas District Office | CGMP Requirements of the Quality System Regulations/Adulterated/Misbranded | N/A * |
| October 16, 2001 | B.F. Ascher & Company, Inc. | Center for Drug Evaluation and Research | Labeling/Unapproved New Drug/Misbranded | N/A * |
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