FDA WARNING_LETTER - Fehling Instruments GmbH & Co. KG - June 18, 2015

On October 13, 2015, the FDA issued a Warning Letter to Fehling Instruments GmbH & Co. KG following a June 15-18, 2015, inspection. The inspection revealed that the firm's cardiac biopsy instruments, ronguers, bone punches, and scissor instruments are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Failure to establish and maintain CAPA procedures (21 CFR 820.100):** Procedures lacked requirements for data analysis, verification/validation of actions, information dissemination, management review submission, and documentation of activities. CAPA records were incomplete. 2. **Failure to establish and maintain complaint handling procedures (21 CFR 820.198):** Procedures did not ensure documentation of oral complaints, formal unit review, uniform/timely processing, MDR reportability evaluation, or complete investigation records. 3. **Failure in design control procedures (21 CFR 820.30(c), (f), (e)):** Lacked requirements for review/approval of design inputs, documentation of design verification results, and formal documented design reviews at appropriate stages. 4. **Failure to document rework activities (21 CFR