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.
Microsurgical Technologies Redmond, WA (3/1). Inspected 11/8-10 and 21/05. QSR deviations, adulterated: Company failed to review and evaluate complaints in a timely manner. The FDA investigator found eight complaints that were not completed and closed. During 2003 and 2004 quality audit schedules, the firm cited need for corrective actions in Regulatory Affairs, Engineering, Manufacturing, Purchasing, Customer Service, Shipping/Receiving, and Service-Repair. Yet it failed to document these corrective actions as completed or closed. Also the corrective and preventive action (CAPA) procedures do not indicate under what conditions a corrective action is raised to the CAPA level. Investigations on three CAPA requests were inadequate because the company failed to document the analysis of the scope of the identified problem to include whether multiple components, devices, or lots were affected by the problem, etc. (Phaco Needles and Tips and the Oculo-Pressor ophthalmic surgical devices); FDCA 501(h), 21CFR 820.198(a)(1), 820.100(a)(1)&(3), 820.70(b), 820.100(b) (SEA 06-19)
http://www.fda.gov/foi/warning_letters/g5749d.pdf Water Oz Grangeville, ID (3/8). Reviewed Web site at www.wateroz.com Unapproved new drugs, misbranded: Claims cause the products to be drugs. For example, labeling for germanium states: "Germanium is also believed to act as an anti-cancer agent, has proved itself effective in viral, bacterial and fungal infections and is known to stimulate production of natural killer cells and T-suppressor cells," etc. (germanium, gold, platinum, chromium, boron, basil, holy basil, etc.); FDCA 502(f)(1), 505 (SEA 06-21) http://www.fda.gov/foi/warning_letters/g5752d.pdf
