The FDA has issued the following warning letters in 2012: The link for the warning letters can be found here.
Office of Compliance/Immediate Office
| Company/Individual | Product/Issue | Issue Date |
|---|---|---|
| C.I. Farmacapsulas S.A. (WARNING LETTER) | failure to register | 5/15/12 |
| Sal Pharma (WARNING LETTER) | failure to register | 4/24/12 |
| Peking Medicine Manufactory (WARNING LETTER) | failure to register | 4/5/12 |
| Korea Pharma Company Ltd (WARNING LETTER) | failure to register | 3/26/12 |
| Orlane S.A. (WARNING LETTER) | failure to register | 3/15/12 |
| Pan Drugs Limited (WARNING LETTER) | failure to register | 2/28/12 |
| Chinese Peptide Company (WARNING LETTER) | failure to register | 2/28/12 |
| Zhejiang Xianju Chemical Pharmaceutical Factory (WARNING LETTER) | failure to register | 1/25/12 |
Office of Drug Security, Integrity and Recalls
| Company/Individual | Product/Issue | Issue Date |
|---|---|---|
Office of Unapproved Drugs and Labeling Compliance
| Company/Individual | Product/Issue | Issue Date |
|---|---|---|
Office of Manufacturing and Product Quality
| Company/Individual | Product/Issue | Issue Date |
|---|---|---|
| B.M.P. Pharma Trading AG (WARNING LETTER) | manufacture of APIs | 5/4/12 |
| Selder S.A. de C.V. (WARNING LETTER) | regulations for finished pharmaceuticals | 4/27/12 |
| Tedec-Meiji Farma, S.A. (WARNING LETTER) | regulations for finished pharmaceuticals | 4/24/12 |
| UNAM, Facultad De Estudios Superiores Cuautitlan (WARNING LETTER) | manufacture of APIs | 3/24/12 |
| manufacture of APIs | 3/9/12 | |
| Pax-All Manufacturing, Inc. (WARNING LETTER) | significant violations of Current Good Manufacturing Practice (CGMP) | 3/9/12 |
| Laboratorios Jaloma S.A. de C.V. (WARNING LETTER) | significant violations of Current Good Manufacturing Practice (CGMP) | 3/9/12 |
| Nobilus Ent (WARNING LETTER) | manufacture of APIs | 3/7/12 |
| regulations for finished pharmaceuticals | 2/23/12 | |
| Gulf Pharmaceutical Industries (WARNING LETTER) | significant violations of Current Good Manufacturing Practice (CGMP) | 2/23/12 |
Office of Scientific Investigations
| Company/Individual | Product/Issue | Issue Date |
|---|---|---|
| Merck Sharp and Dohme Corp. (WARNING LETTER) | Postmarket Requirements (PMRs) | 2/17/12 |
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