FDA WARNING_LETTER - Lac-Mac Limited - November 06, 2014

On November 3-6, 2014, an FDA inspection of Lac Mac, Ltd. in London, Ontario, identified that their surgical gowns, sterile wraps, and surgical drapes 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 November 25, 2014, response to the FDA 483 was deemed inadequate.

Key violations include: 1. **Design Control (21 CFR 820.30(a)):** Failure to establish and maintain procedures ensuring design input/output, verification, validation, review, changes, and transfer are documented. DHFs lacked this information. The firm's revised procedures were insufficient without a retrospective DHF review. 2. **CAPA (21 CFR 820.100(a)):** Inadequate CAPA procedures lacking requirements for data analysis, investigation, action identification, verification/validation, implementation, information dissemination, management review submission, and documentation. Specific CAPA records (137, 138, 143, 144) lacked investigation results, validation, and implementation dates. CAPA 138, concerning barcode complaints, lacked documented verification/validation of corrective actions. The firm's revised CAPA