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.
Anicare Pharmaceutical Mumbai, India (2/28): FDA inspected the firm 8/2018 and cited significant GMP violations for finished pharmaceuticals. For example, Anicare failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates. The company’s quality control unit did not review and approve written procedures for production and process control, including any changes to them, designed to ensure that the drug products have the identity, strength, quality, and purity they purport to possess.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm633150.htm
Jubilant Life Sciences Pradesh, India (3/6): FDA inspected the firm’s drug manufacturing facility 8/2018 and cited significant GMP violations for finished pharmaceuticals. For example, Jubilant failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications. The company’s quality control unit failed to test and reject in-process materials that did not conform to appropriate testing during the production process. FDA noted that it found repeat violations that were originally cited in 2016. It recommended that Jubilant retain a GMP consultant to help resolve all deficiencies and systemic flaws.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm633184.htm
Laboratorios Quantium Medley, FL (2/25): FDA inspected the firm 8/2018 and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to establish an adequate quality control unit and procedures applicable to the quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products. The firm also failed to withhold from use each lot of components, drug product containers, and closures until the lot had been sampled, tested, or examined and released for use by the quality control unit.https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm632709.htm
Pfizer (Hospira) New York, NY (3/4): FDA inspected a Hospira India facility 4/2018 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards. Hospira also failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications. Additionally, the company failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release. The inspection also took issues with Hospira’s quality system because it does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs it manufactures.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm633096.htm