FDA WARNING_LETTER - Stat Medical Devices, Inc. - February 20, 2015

On February 18-20, 2015, an FDA inspection of Stat Medical Devices, Inc. in North Miami Beach, Florida, identified that the firm, a specification developer of various blood lancets and sampling devices, was not in conformity with Quality System regulation (21 CFR Part 820). This rendered their devices adulterated under section 501(h) of the Act.

Violations included: 1. **Failure to document CAPA activities and results (21 CFR 820.100(b)):** Corrective Action Reports (CARs) for nonconformances (e.g., needle sticks, needles falling out) lacked documented root cause, impact, corrective/preventive actions, and effectiveness determination, despite being marked "Satisfactory." The firm's response was inadequate as no supporting evidence of implementation was provided. 2. **Failure to validate and monitor processes (21 CFR 820.75(a) & (b)):** The firm lacked documentation for sterilization validation and requalification assessments for their current sterilization process, making it unclear how they concluded there was "no risk" to sterilized products. 3. **Failure to establish adequate purchasing controls (21 CFR 820.50):** The firm did not implement procedures to verify vendor qualification for sterilization services, maintain quality agreements with critical sterilization vendors, or obtain written consent from foreign