Multimedical S.R.L. – FDA Warning Letter, Oct 23, 2014

On February 13, 2015, the FDA issued a Warning Letter to Multimedical S.R.L. following an inspection from October 20-23, 2014, at their facility in Viadana, Italy. The inspection revealed that the firm's medical devices, including I.V. infusion sets and hemodialysis blood lines, were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(t)(2) for failing to comply with Medical Device Reporting (MDR) requirements (21 CFR Part 803).

Key violations included: 1. **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a))**: The firm's CAPA procedure lacked requirements for analyzing quality data, using statistical methodology, and verifying/validating corrective actions. Additionally, the firm failed to evaluate EtO degassing issues contributing to unacceptable EtO residue on sterilized products. The firm's response was deemed inadequate as the revised procedure did not address deficiencies, and risk associated with released devices was not evaluated. 2. **Failure to establish and maintain procedures for purchased products and services (21 CFR