Inspections, Compliance, Enforcement, and Criminal Investigations
2005 Warning Letters
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Warning Letters issued in 2005
* 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 February 02, 2009
| Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
|---|---|---|---|---|
| November 29, 2005 | BODeSTORE.com | New Jersey District Office | Labeling/Promotional Claims False & Misleading/New Drug/Misbranded | N/A * |
| November 28, 2005 | Spectrum Chemicals & Laboratory Products, Inc | New Jersey District Office | Active Pharmaceutical Ingredients/Misbranded | N/A * |
| November 28, 2005 | Sacred Mountain Management Inc | Denver District Office | Labeling/Promotional Claims False & Misleading/New Drug/Misbranded | N/A * |
| November 23, 2005 | PRB Pharmaceuticals | Los Angeles District Office | Labeling/Promotional Claims False & Misleading/New Drug/Misbranded | N/A * |
| November 23, 2005 | PolyCil Health Inc | Los Angeles District Office | Labeling/Promotional Claims False & Misleading/New Drug/Misbranded | N/A * |
| November 23, 2005 | The Electrode Store, Inc. | Seattle District Office | Current Good Manufacturing Practices Requirements for Medical Devices/Adulterated | N/A * |
| November 22, 2005 | NativeRemedies.com | Center for Biologics Evaluation and Research | Promotional Claims False & Misleading/Misbranded | N/A * |
| November 22, 2005 | Milbank Mills Inc | Kansas City District Office | CGMP for Medicated Feeds/Adulterated | N/A * |
| November 22, 2005 | Corin USA | Center for Devices and Radiological Health | Lacks Premarket Approval Application Adulterated | N/A * |
| November 22, 2005 | Kramer Laboratories Inc. | Florida District Office | Labeling/Promotional Claims False & Misleading/New Drug/Misbranded | N/A * |
| November 22, 2005 | G&S Instrument Company | Dallas District Office | CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated | N/A * |
| November 21, 2005 | Medina & Medina, Inc | San Juan District Office | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | N/A * |
| November 21, 2005 | Revival Animal Health, Inc. | Kansas City District Office | Promotional Claims False & Misleading/Adulterated/Misbranded | N/A * |
| November 18, 2005 | Normed Medizin-Technik GmbH | Center for Devices and Radiological Health | CGMP for Medical Devices/QSR/Adulterated/Misbranded | N/A * |
| November 16, 2005 | LA Fish Company | Los Angeles District Office | Seafood HACCP/Adulterated | N/A * |
| November 16, 2005 | Chun Cheng USA Inc. | Los Angeles District Office | Seafood HACCP/Adulterated | N/A * |
| November 16, 2005 | Scientific Laboratories, Inc. | Baltimore District Office | CGMP for Finished Pharmaceuticals/Adulterated | N/A * |
| November 16, 2005 | Globalemed, LLC | Baltimore District Office | Current Good Manufacturing Practice Regulation/Adulterated | N/A * |
| November 16, 2005 | Four Brothers Dairy, Incorporated | Seattle District Office | Illegal Drug Residue /Adulterated | N/A * |
| November 16, 2005 | Majestic International Spice | Los Angeles District Office | Import/Lacks May Proceed or Release Notice | N/A * |







