FDA WARNING_LETTER - EUROMI S.A. - January 15, 2015

On January 12-15, 2015, an FDA inspection of Euromi S.A. in Verviers, Belgium, revealed that their EVA Sp Liposuction System devices are 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 provide required information under 21 U.S.C. § 360i and 21 CFR Part 803 (Medical Device Reporting).

Key violations include: 1. **Purchasing Controls (820.50):** Failure to ensure purchased products/services conform to requirements, e.g., contract sterilizer did not validate sterilization of disposable tubing sets. 2. **Complaint Handling (820.198(a)):** Inadequate procedures for receiving, reviewing, and evaluating complaints, including lack of uniform processing, documentation of oral complaints, complete investigation records, reasons for no investigation, and MDR reportability evaluation. Specific complaints (105, 132) regarding broken cannula tips lodged in patients were not investigated or evaluated for MDR reportability. 3. **Corrective and Preventive Action (CAPA) (820.