FDA WARNING_LETTER - Medsys s.a. - September 20, 2012

On September 17-20, 2012, an FDA inspection of Medsys s.a. in Gembloux, Belgium, revealed significant violations of the Federal Food, Drug, and Cosmetic Act for their Lap Loop Systems, classified as medical devices. The firm's responses to the FDA 483 observations were deemed inadequate.

Key violations include: 1. **Design Control (21 CFR 820.30(i)):** Failure to establish adequate procedures for design changes, with 200 increased-length Lap Loop Systems distributed without prior validation/verification, review, and approval. 2. **Complaint Handling (21 CFR 820.198(a)):** Inadequate procedures for receiving, reviewing, and evaluating complaints, including lack of timely processing, documentation of oral complaints, and determination of MDR reportability. 3. **Nonconforming Product (21 CFR 820.90(a)):** Failure to control nonconforming products, with instances of missing components not evaluated or investigated. 4. **Incoming Product Acceptance (21 CFR 820.80(b)):** Absence of written procedures for assuring acceptance of incoming products. 5. **Finished Device Acceptance (21 CFR 820.80(d)):** Lack of written procedures for final acceptance activities of finished devices. 6.