FDA WARNING_LETTER - THD SpA - November 08, 2012

On November 5-8, 2012, an FDA inspection of THD S.p.A. in Correggio, Italy, revealed that their Rectoscopes, Anescopes, Proctoscopes, and Doppler Systems devices were adulterated. The firm's manufacturing, packing, storage, or installation methods and controls did not conform to the Quality System regulation (21 CFR Part 820).

Key violations included: 1. Failure to establish and maintain complaint handling procedures, specifically regarding MDR evaluation (21 CFR 820.198(a)). 2. Failure to review and evaluate all complaints to determine investigation necessity, including documenting reasons for not investigating (21 CFR 820.198(b)). 3. Failure to establish and maintain corrective and preventive action (CAPA) procedures, with inadequate documentation and verification/validation of actions (21 CFR 820.100(a)). 4. Failure to establish and maintain design verification procedures, lacking documentation of results in design history files (21 CFR 820.30(f)). 5. Failure to establish and maintain procedures for formal documented design reviews, with inadequate participant representation (21 CFR 820.30(e)). 6. Failure to adequately validate processes where results cannot be fully verified by subsequent inspection and test (21 CFR 820