FDA WARNING_LETTER - CORIN MEDICAL, LTD. - March 05, 2015

On September 14, 2015, the FDA issued a Warning Letter to Corin Medical Ltd. following an inspection from March 2-5, 2015, which found their knee prosthesis systems to be adulterated under 21 U.S.C. §351(h) due to non-conformity with Quality System regulation (21 CFR Part 820).

Violations included: 1. Failure to establish and maintain CAPA procedures (21 CFR 820.100(a)), specifically lacking effectiveness verification for corrective actions. 2. Failure to establish and maintain finished device acceptance procedures (21 CFR 820.80(d)), with inadequate visual inspection standards for surface roughness. 3. Failure to validate processes not fully verifiable by subsequent inspection (21 CFR 820.75(a)), concerning specific dimensional features. 4. Failure to adequately define nonconforming product review and disposition procedures (21 CFR 820.90(b)), with insufficient justification for accepting out-of-tolerance products. 5. Failure to document acceptance activities (21 CFR 820.80(e)), specifically lacking documentation for incoming material testing. 6. Failure to establish and maintain design verification procedures (21 CFR 820.30(f)), with design verifications lacking