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.
Ausmetics Daily Chemicals (Guangzhou) Co. Guangdong, China (1/31): FDA inspected the firm 7/2016 and cited significant GMP violations related to finished pharmaceuticals. For example, the firm failed to perform, 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. Additionally, it found that the firm failed to ensure that its drug product bore an expiration date that was supported by appropriate stability testing.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm540306.htm
Broadmaster Biotech Corp. Zhongli City, Taiwan (10/4/2016): FDA inspected the firm 5/2016 and documented GMP deviations with its manufacture of blood glucose meters. For example, FDA found that the firm failed to establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. It also found that it failed to evaluate complaints to determine whether a complaint represents an event which is required to be reported to FDA under part 803.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm540783.htm
Hubei Hongkang Protective Products Co. Huanggang City, Hubeisheng, China (9/15/2016): FDA inspected the firm 6/2016 and documented GMP deficiencies related to its manufacture of surgical masks, conductive shoes and shoe covers, examination gowns, surgical suits, surgical dresses, surgical caps, scavenging masks, disposable medical bedding, surgical apparel accessories, non-surgical isolation gowns and impervious non-surgical isolation gowns. The firm failed to allow FDA to complete its inspection and the agency has placed the devices on import alert.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm540542.htm
Resonance Laboratories Pvt. Ltd. Bangalore, India (2/3): FDA inspected the firm 5/2016 and cited GMP deviations with its active pharmaceutical ingredients manufacturing. For example, FDA said the firm failed to validate that its water system is capable of consistently producing water suitable for its intended use. Additionally, the firm failed to have adequate cleaning procedures to prevent contamination or carry-over of a material that would alter the quality of the API.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm540822.htm
Sato Pharmaceutical Co., Ltd. Tokyo, Japan (2/2): FDA inspected the firm 2/2016 and cited GMP violations related to finished pharmaceuticals. For example, the firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas. The firm also failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products. Based upon the nature of the violations, FDA recommended that the firm retain a consultant to assist it in meeting GMP requirements.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm540820.htm
Thermogram Assessment Services Palos Verdes, CA (11/10/2016): FDA has learned that the firm is marketing the TAS Image Analysis Software, including the Spatial Thermographic Imaging (STI), the Integrated Thermography Systems, and Infrared (IR) Cameras (FLIR Systems, Inc. Model 325 and Model 655) without marketing clearance or approval. FDA notes that the IR cameras have been cleared for a certain intended use, but marketing the cameras with a major change or modification in intended use would not fall under their current clearance.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm540528.htm
Zhejiang Bangli Medical Products Co. Yongkang City, Zhejiang Province,China (1/26): FDA inspected the firm 8/2016 and cited GMP violations related to finished pharmaceuticals. For example, FDA says the firm does not have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications. Additionally, the firm failed to test samples of each component for conformity with all appropriate written specifications for purity, strength, and quality.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm540251.htm