FDA WARNING_LETTER - Farmacia La Salud Inc. - May 31, 2007

An FDA inspection of Farmacia La Salud Inc. in Caguas, PR, from May 10-31, 2007, revealed serious violations of the Federal Food, Drug, and Cosmetic Act (FDCA). The firm's large-scale production of inhalation solutions, including copies of commercially available FDA-approved products, was deemed akin to drug manufacturing, exceeding traditional pharmacy compounding. Consequently, the compounded drugs are considered unapproved new drugs under FDCA sections 505(a) and 301(d). The products are also misbranded due to inadequate labeling (FDCA 502(f)(1), 21 CFR 201.115) and the firm's failure to register and list its products (FDCA 502(o), 510, 510(j)). Furthermore, the inhalation solutions are adulterated under FDCA 501(a)(2)(B) because manufacturing controls and procedures do not conform to current Good Manufacturing Practice (CGMP) regulations (21 CFR Parts 210 and 211). Specific CGMP violations include failures in preventing microbiological contamination (21 CFR 211.113(b)), sterility and pyrogen testing (21 CFR 211.167(a)), final product testing (21 CFR 211.165(a)), equipment cleaning validation (21 CFR 211.67(b)), component release by quality control (21 CFR 211.84(a)), complete batch records (21 CFR 211.188(b)), stability testing for expiration dates (21 CFR 211.137(a)), complaint handling procedures (21 CFR 211.198), and distribution procedures for recalls (21 CFR 211.150(b)). The firm's January 22, 2008, response to the FDA-483 was largely deemed inadequate. Farmacia La Salud Inc. must promptly correct these violations within fifteen working days, providing documentation of corrective actions, or face potential legal action, including seizure and injunction, without further notice.