FDA WARNING_LETTER - First Medical Source LLC - May 22, 2012

On September 26, 2012, the FDA issued a Warning Letter to First Medical Source, LLC, following an inspection from April 26 to May 22, 2012, which found their "First Medical Source (FMS) Pain Management Kits" to be adulterated and misbranded.

The devices were deemed adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). Violations included: 1. **Design Control (21 CFR 820.30(a)):** Failure to establish and maintain adequate procedures for device design, lacking documentation for design input, output, verification, and validation. 2. **Corrective and Preventive Action (CAPA) (21 CFR 820.100(a)):** Inadequate CAPA procedures and documentation, including lack of effectiveness verification for corrective actions, incomplete investigations into non-conformities (e.g., leakage issues), and insufficient records for various CAPAs. 3. **Acceptance Activities (21 CFR 820.80(a)):** Absence of procedures for accepting incoming products from suppliers and for ensuring final kit specifications are met. 4. **Complaint Handling (21 CFR 820.198(a)):**