Pace Tech, Inc. – FDA Warning Letter, Jul 13, 2011

On November 1, 2011, the FDA issued a Warning Letter to Pace Tech, Inc. following an inspection from July 7-13, 2011, which found their Vitalmax 4000 Patient Monitoring Device to be adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Corrective and Preventive Action (CAPA)** (21 CFR 820.100(a)): Failure to establish and maintain adequate CAPA procedures, including lack of quality data reviews (2008-April 2011), no verification/validation of CAPA effectiveness, and improper documentation of root cause investigations. The firm's response was inadequate, lacking proof of training and systemic retrospective review. 2. **Purchasing Controls** (21 CFR 820.50(a)): Inadequate supplier evaluation procedures, allowing acceptable scores even with zero in the quality category. The revised form was noted, but training and systemic evaluation of existing suppliers were not documented. 3. **Nonconforming Product** (21 CFR 820.90(b)(1)): Failure to define responsibility and authority for nonconforming product disposition, evidenced by an undocumented scrap decision. The