Atossa Genetics, Inc. – FDA Warning Letter, Jul 25, 2012

On July 16-25, 2012, an FDA inspection of Atossa Genetics in Seattle, Washington, revealed their MASCT System and Collection Kit devices were adulterated under 21 U.S.C. § 351(h) due to non-conformity with cGMP requirements of 21 CFR Part 820. The firm's August 6, 2012, response to the FDA 483 was deemed inadequate.

Violations included: 1. Failure to establish and maintain design control procedures (21 CFR 820.30(a)). 2. Failure to establish and maintain procedures for design changes, with undocumented changes to the MASCT System filter and lack of design inputs/outputs/verification for current changes (21 CFR 820.30(i)). 3. Failure to establish and maintain corrective and preventive action procedures (21 CFR 820.100(a)). 4. Failure to maintain adequate complaint files and procedures, with unfiled complaints regarding MASCT System funnel thread breakage (21 CFR 820.198(a)). 5. Failure to maintain adequate records of complaint investigations, lacking required information (21 CFR 820.198(e)). 6. Failure to establish and maintain adequate requirements for suppliers, contractors, and