Today FDA posted its latest batch of Warning Letters. They can be accessed in Adobe PDF format by clicking on the link following each letter.
F.H.G Corp. Sarasota, FL (8/22). Inspected 3/23-4/11. Misbranded: Therapeutic claims made for NutraVitals Cinnulin PF cause the product to be an unapproved drug. For example, a product brochure states, “The polyphenolic polymers in cinnamon bark … may provide synergistic benefits to persons with various forms of diabetes,” etc. (Cinnulin PF); FDCA 502(f)(1), 505(a) (FLA-07-30)
http://www.fda.gov/foi/warning_letters/s6513c.pdf
Kunshan Chemical and Pharmaceutical Co., Ltd. Kunshan City, Jiangsu, China (9/6). Inspected 4/07. GMP deviations, adulterated: Batch production records do not include complete information relating to the production and control of each API batch. Both the old and new facilities show a pattern of non-compliance with CGMP documentation and records requirements. Method validation documentation did not include appropriate data to verify that the analytical method produced accurate and reliable results. Production equipment was not adequately cleaned and was not maintained in a good state of repair, etc. (active pharmaceutical ingredients); FDCA 501(a)(2)(B) (WL: 320-07-02)
http://www.fda.gov/foi/warning_letters/s6512c.pdf
Leiner Health Products Carson, CA (8/28). Inspected 1/22-3/16. GMP deviations, adulterated: Company failed to properly assess the stability characteristics of the drug products manufactured or repackaged at the site. There is no assurance that any of the OTC products in distribution have adequate impurity stability data to support their expiration dates. Review of impurity testing (chromatography) for stability samples (purged) revealed impurities which were consistently ignored. Company had an inadequate quality control unit and inadequate laboratory facilities available for the testing and approval of components, in-process materials, drug products, and all procedures or specifications impacting identity, strength, quality and purity of the products. The company’s consultant revealed at a 6/12 meeting at the Atlanta District’s office that a cultural assessment review conducted at the Fort Mill site revealed that upper management responsible for overseeing the quality control unit was “out of touch” with the events occurring, had “minimal presence,” and was “largely unaware of the quality concerns in the laboratory” at the site, etc. (drug products); FDCA 501(a)(2)(B), 211.166, 211.137, 211.22(a-c), 211.166(a)(3) (07-ATL-10)
http://www.fda.gov/foi/warning_letters/s6511c.pdf
