FDA WARNING_LETTER - Innovacyn Inc. - December 02, 2011

The FDA issued a Warning Letter to Innovacyn, Inc. concerning its Vetericyn brand veterinary products, including wound care, eye wash, and other treatments for various animals. This action followed a review of the firm's promotional materials and an FDA inspection conducted from November 21 to December 2, 2011. The FDA determined that Vetericyn products are unapproved new animal drugs, violating sections 512(a), 501(a)(5), and 301(a) of the Federal Food, Drug, and Cosmetic Act. The products are marketed with claims of treating infections, promoting healing, and possessing antimicrobial effects (e.g., killing 99.999% of pathogens), which classify them as drugs, not devices, and they lack the required approvals. The inspection also revealed significant Current Good Manufacturing Practice (CGMP) violations (21 C.F.R. Parts 210 and 211), rendering the products adulterated under section 501(a)(2)(B). Specific deficiencies included the Quality Control Unit's failure to thoroughly investigate numerous consumer complaints as required by 21 C.F.R. §§ 211.192 and 211.198, and the firm's failure to establish adequate laboratory controls, including microbial specifications and testing for purified water, as mandated by 21 C.F.R. § 211.160(b). Innovacyn must promptly correct all violations and notify the FDA within fifteen working days with a detailed corrective action plan, including steps to prevent recurrence and a timeline for completion. Failure to comply could lead to enforcement actions like seizure or injunction, and impact federal contracts, as unapproved products are subject to market removal.