FDA WARNING_LETTER - MB Industria Cirurgica Ltda - March 16, 2017

On March 13-16, 2017, an FDA inspection of MB Industria Cirurgica Ltda in Paulista, Brazil, revealed that their wound dressings 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. **Process Validation (21 CFR 820.75(a))**: Failure to validate manufacturing processes for the (b)(4) device, including (b)(4) and packaging to ensure sterility. 2. **Environmental Control (21 CFR 820.70(c))**: Lack of documentation for cleanroom installation/testing (ISO 14644), non-compliance with cleanroom specifications (ISO Class 8 instead of Class 7, temperature excursions), inadequate procedures for cleanroom conditions after power outages, and no environmental control program for cleanliness/biocontamination. 3. **CAPA (21 CFR 820.100(a))**: Inadequate procedures for corrective and preventive actions, failing to analyze quality data (e.g., increased leakage complaints) and disseminate quality problem information. 4. **Complaint Handling (21 CFR 820.198(a))**: Inadequate procedures for timely processing, documenting oral