FDA WARNING_LETTER - AYGUN CERRAHI ALETIER A.S.SURGICAL INSTRUMENTS CO. - April 18, 2013

On April 15-18, 2013, an FDA inspection of Aygun Cerrahi Aletler A.S. in Samsun, Turkey, revealed that their sterile container systems, classified as medical devices, were adulterated. The manufacturing, packing, storage, or installation methods did not conform to the Quality System regulation (21 CFR Part 820).

The firm's May 3, 2013, response to the FDA 483 was deemed inadequate as it lacked evidence of corrective actions. Violations included: 1. Failure to establish and maintain procedures for translating device design into production specifications (21 CFR 820.30(h)). 2. Failure to validate processes where results cannot be fully verified by subsequent inspection and test (21 CFR 820.75(a)), specifically for a (b)(4) process. 3. Failure to establish and maintain procedures for identifying, documenting, validating/verifying, reviewing, and approving design changes before implementation (21 CFR 820.30(i)). 4. Failure to document all required activities and their results, particularly in Corrective and Preventive Action (CAPA) records (21 CFR 820.100(b)). 5. Failure to establish and maintain procedures for changes to specifications, methods, processes, or procedures (21 CFR 820