Latest FDA Warning Letters
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.
Apotex Research Private Ltd. Bangalore, India (8/9): FDA inspected the firm 11/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to thoroughly investigate all unexplained discrepancies or failures of a batch or any of its components to meet any of its specifications. The firm also failed to establish valid in-process specifications.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm616444.htm
Paramesh Banerji Life Sciences North Brunswick, NJ (8/7): FDA inspected the firm 12/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to establish adequate written procedures for production and process controls. It also failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm616299.htm
Signature Formulations Phoenix, AZ (7/31): FDA inspected the firm 11/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for its drug products. The firm also failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all drug products and with the responsibility for approving or rejecting procedures or specifications.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm616278.htm
JT Cosmetics & Chemicals Gujarat, India (7/27): FDA inspected the firm in February and documented significant GMP violations for finished pharmaceuticals. For example, the firm failed to perform, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications. The firm also failed to test samples of each component for conformity with all appropriate written specifications for identity, purity, strength, and quality. FDA said the firm’s quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs it manufactures. The agency further requested a comprehensive investigation into the extent of the inaccuracies in data, records, and reporting, including results of a data review for drugs distributed to the U.S.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm615992.htm
Yicheng Goto Pharmaceuticals Co. Xiangyang, China (7/26): FDA inspected the firm 9/2017 and cited significant GMP deviations for active pharmaceutical ingredients. For example, the firm failed to adequately validate the process for cleaning and maintenance of equipment. It also failed to ensure that all test procedures are scientifically sound and appropriate to ensure that the APIs conform to established standards of quality and purity.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm616310.htm
North American Science Associates Minneapolis, MN (3/23): FDA performed a bioresearch monitoring inspection at the contract laboratory 11/2017 to verify Good Laboratory Practices related to several PMA submissions. The inspected cited the firm for failure of its study director to fulfill his or her responsibilities. It also was cited for failing to adequately identify study specimens. Additionally, FDA cited it for failing to provide for orderly storage and expedient retrieval of all raw data, documentation, protocols, specimens, and interim and final reports, and to have an archive index.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm615970.htm