FDA WARNING_LETTER - Ogenix Corporation - March 01, 2012

On March 27, 2012, the FDA issued a Warning Letter to Ogenix Corporation following an inspection from February 13 to March 1, 2012, at their Beachwood, Ohio facility. The inspection determined Ogenix is a specification developer for the EpiFLO topical oxygen system, classified as a device under 21 U.S.C. § 321(h). The devices were found to be adulterated under 21 U.S.C. § 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System regulation (21 C.F.R. Part 820).

Violations included: 1. Failure to establish and maintain procedures for purchased products and services (21 C.F.R. § 820.50), specifically not implementing the "Supplier Management Procedure" for critical suppliers and not including the membrane electrode assembly supplier on the approved list. 2. Failure to validate new EpiFLO designs (7-Day and 15-Day devices released August 2006) to ensure conformity to user/patient needs (21 C.F.R. § 820.30(g)). 3. Failure to adequately establish design inputs for device requirements, including strength and durability for devices worn 24/7,