FDA WARNING_LETTER - Aros Surgical Instruments Corporation - February 06, 2015

On September 25, 2015, the FDA issued a Warning Letter to Aros Surgical Instruments Corporation following a February 2-6, 2015 inspection. The inspection found that the firm's surgical sutures and micro anastomosis clamps were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations included: 1. **Failure to establish and maintain design control procedures (21 CFR 820.30(a)(1))**: No design control documentation for surgical sutures; retrospective file inadequate. 2. **Failure to control design changes (21 CFR 820.30(i))**: Implemented sterilization method changes (e.g., to E-Beam for sutures), material changes, and new designs (curved clamps, different closing forces) without proper validation, verification, or documentation. 3. **Inadequate purchasing controls (21 CFR 820.50)**: No procedures to ensure suppliers meet quality requirements. 4. **Failure to maintain supplier requirements and agreements (21 CFR 820.50(b))**: No records of specified requirements for contract manufacturers or agreements for notification of product changes. 5. **Failure to establish a design history file (21 CFR 820.