Instratek, Incorporated – FDA Warning Letter, Apr 24, 2012

During an April 2-24, 2012, inspection, the FDA found Instatek, Inc., a manufacturer of orthopedic implant systems (e.g., Sub-Talar Lok, Michelangelo Bunion System), in violation of Quality System (QS) regulation (21 CFR Part 820) requirements, rendering their devices adulterated. The firm's responses from May to July 2012 were incomplete or partially adequate.

Violations included: 1. **Design Validation (21 CFR § 820.30(g)):** Failure to validate pre-vacuum steam sterilization cycles for Sub-Talar Lok and Michelangelo Bunion System (MABS) and to adequately address gravity displacement steam sterilization. Risk analysis for Sub-Talar Lok instruments was incomplete, and a design validation plan/protocol was missing. 2. **Design Input (21 CFR § 820.30(c)):** Incomplete or ambiguous design input requirements for the Sub-Talar Lok Implant System and its accessories, lacking technical specifications and measurable requirements. 3. **Finished Device Acceptance (21 CFR § 820.80(d)):** Incorrect measurement of Sub-Talar implants during inspection and failure to document nonconforming inspection results for rejected lots. 4. **Corrective and Preventive Action (CAPA) (21 CFR § 820.10