FDA WARNING_LETTER - Medys S.p.A. - December 13, 2012

On December 10-13, 2012, an FDA inspection of Medys S.p.A. in Milan, Italy, revealed that their x-ray collimators, mammography compression supports/plates, bucky rad film holders, and ionization chambers are adulterated. The manufacturing, packing, storage, or installation methods do not conform to the Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Complaint Files (21 CFR 820.198(a)):** Failure to maintain adequate complaint files, document all complaints (especially those without returned products), and evaluate complaints for Medical Device Reporting (MDR) reportability. 2. **Corrective and Preventive Action (CAPA) (21 CFR 820.100(a)):** Inadequate procedures for implementing CAPAs, failure to document all non-compliances, and not following procedures for opening and maintaining CAPAs. 3. **Quality Audits (21 CFR 820.22):** Failure to conduct annual quality audits as per procedures, audits performed by individuals with direct responsibility, and auditors lacking knowledge of relevant regulations (21 CFR 803, 820). 4. **Computer System Validation (21 CFR 820.70(i)):** No documented revalidation plan or summary for