dsaart, llc. – FDA Warning Letter, Aug 5, 2021

The FDA issued a Warning Letter to a manufacturer of silicone facial and body contouring implants following an inspection from July 19 to August 5, 2021. The inspection revealed the firm's devices are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(t)(2) for failing to furnish required information under 21 U.S.C. § 360i and 21 CFR Part 803 (Medical Device Reporting).

Key violations include: 1. **Process Validation (21 CFR 820.75(a)):** Failure to validate sterilization, silicone curing, and packaging sealing processes. The firm's responses were inadequate, lacking validation plans and interim actions. 2. **Complaint Files (21 CFR 820.198(a)):** Inadequate documentation of complaint details, investigation results, and justifications for not investigating. Redocumentation of complaints was deemed insufficient. 3. **Corrective and Preventive Action (CAPA) (21 CFR 820.100(a)):** Failure to adequately implement CAPA procedures, specifically regarding assessing the impact of process nonconformances.