Latest FDA Warning Letters
Here are the FDA Warning Letters that were released during the FDA Webview’s holiday break at the end of December:
AN Co. Ltd. Gyeonggi-do, Korea (12/13/2017): FDA inspected the firm 5/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any specifications. The firm also failed to 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.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm590188.htm
Amaros Co., Ltd. Seongnam-si, Korea (12/13/2017): FDA inspected the firm 5/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to establish a 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, including drug products manufactured, processed, packed or held under contract by another company. Additionally, the firm failed to have written procedures describing the receipt, identification, storage, handling, sampling, examination, and testing of labeling and packaging materials.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm590011.htm
C.O. Truxton Bellmawr, NJ (12/19/2017): FDA inspected the firm 6/2017 and cited significant GMP violations. For example, the firm failed to establish a quality control unit for its drug repackaging operation and it lacked written procedures for production or quality unit responsibilities. The firm also failed to have written procedures covering the application of packaging and labeling materials for its drug products.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm590035.htm
Fresenius Kabi AG Bad Homburg, Germany (12/4/2017): FDA inspected the firm 5/2017 and cited significant GMP deviations with its active pharmaceutical ingredients (API). For example, the firm failed to adequately investigate and document out-of-specification results according to a procedure. The firm also failed to ensure that all test procedures are scientifically sound and appropriate to ensure that raw materials, intermediate and API conform to established standards of quality and purity.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm589941.htm
Fresenius Kabi Oncology Ltd. Bad Homburg, Germany (12/19/2017): FDA inspected the firm’s facility located in Himachal Pradesh, India 4/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications. Additionally, FDA said a 5/2015 inspection cited a similar GMP observation in which the firm invalidated sterility test failures without adequately investigating the root causes, and failed to take timely and appropriate corrective actions. Despite proposed remediations, FDA said the recent inspection found that the facility’s oversight and control over the manufacture of drugs remain deficient. Inadequate investigations into out-of-specification results is also a recurring issue. The agency recommended that the firm retain a GMP consultant to correct the deficiencies.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm590821.htm
GPC Medical Ltd. New Delhi, India (10/20/2017): FDA inspected the firm 6/2017 and cited GMP deviations with its GPC Bone Plates, GPC Bone Screws, GPC Intramedullary Nailing Systems, and GPC Posterior, Non-Cervical Pedicle Screw Spinal Systems. For example, the firm failed to adequately validate manufacturing processes. Additionally, the firm’s procedures for finished device acceptance have not been adequately established.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm589686.htm
Prosana Distribuciones SA de CV Mexico City, Mexico (12/18): FDA inspected the firm 3/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm distributed two batches of Bicaruvas before receiving certificates of analysis containing the finished product test results from its third-party testing laboratory. The firm also did not test for identity incoming active pharmaceutical ingredients and other components used to manufacture over the counter drug products. Additionally, it failed to establish the reliability of its suppliers’ analyses, and to test each component for conformity with all appropriate written specifications for purity, strength, and quality.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm590494.htm
Telemed Vilnius LT, Lithuania (11/14/2017): FDA inspected the firm 8/2017 and cited GMP deviations with its diagnostic ultrasound systems. For example, the firm failed to establish and maintain adequate design plans that describe or reference the design and development activities. The firm also failed to establish and maintain adequate procedures for design input.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm589996.htm
TruVision Health Draper, UT (11/30/2017): An FDA inspection of the firm cited serious GMP violations for dietary supplements. For example, the firm’s quality control unit failed to approve for release, or reject, any packaged and labeled dietary supplement. It also had no quality control procedures in place. Additionally, a review of the firm’s Web site and related product claims establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm590807.htm