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.
Bayer AG Leverkusen, Germany (11/14/2017): FDA inspected the facility 1/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment. The firm 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 firm failed to establish an adequate 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, and that approves or rejects all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm595730.htm
Cosmecca Korea Co. Eumseong-gun, Korea (2/2): FDA inspected the firm 9/2017 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 the drug product. It also failed to ensure that laboratory records include complete data derived from all tests necessary to assure compliance with established specifications and standards. The agency recommended that the firm retain a GMP consultant to help with achieving compliance.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm595755.htm
Curasan AG Kleinostheim, Germany (8/23/2017): FDA inspected the firm 5/2017 and cited GMP deviations with its medical device manufacturing. For example, the firm failed to establish and maintain procedures for validating device design. The firm also failed to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications. And, it failed to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm595486.htm
Guangzhou Baiyunshan Pharmaceutical Holdings Co. Guangzhou, China (11/1/2017): FDA inspected the firm 5/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to clean, maintain, and sanitize or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination. The firm also failed to follow written procedures for production and process controls designed to assure that its drug products have the identity, strength, quality, and purity they purport to possess. And the firm failed to establish the reliability of the component supplier’s analyses through appropriate validation of the supplier’s test results at appropriate intervals.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm595745.htm
Jiangmen Nowadays Daily Goods Co., Guangdong, China (9/12/2017): FDA inspected the firm 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 the drug product. The firm failed to test samples of each component for conformity with all appropriate written specifications for purity, strength, and quality.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm595725.htm