FDA WARNING_LETTER - Instrumed Gmbh - August 01, 2013

An FDA inspection of Instrumed GmBH in Tuttlingen, Germany, from July 29 to August 1, 2013, revealed that the firm's medical devices, including laparoscopes and surgical instruments, are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). The firm's responses dated September 13, October 28, and December 26, 2013, were largely deemed inadequate.

Key violations include: 1. **Design Validation (21 CFR 820.30(g)):** Inadequate design validation, specifically regarding a voltage warning missing from finished device IFUs, leading to patient injury. 2. **Corrective and Preventive Action (CAPA) (21 CFR 820.100(a)):** Failure to identify actions to prevent recurrence of nonconforming products (e.g., insulation damage, sterilization issues), non-compliance with CAPA procedures (e.g., not escalating supplier issues), and lack of validation documentation for CAPA changes. 3. **Acceptance Activities (21 CFR 820.80(a)):** Inadequate incoming acceptance activities, lacking specific acceptance criteria, calibration tool requirements, and records of actual measurements. 4.