Professional Disposables International, Inc. – FDA Warning Letter, Jun 23, 2021

The FDA inspected Professional Disposables International, Inc. (PDI) from May to June 2021, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Inadequate Out-of-Specification (OOS) Investigations (21 CFR 211.192):** PDI failed to thoroughly investigate OOS results in a timely manner, identify root causes, expand investigations to affected batches, implement corrective and preventive actions (CAPA), and evaluate CAPA effectiveness. Specific examples cited for Prevantics Swabstick and Swab batches (12000124, 11900228ES, 11800257JS) showed unsupported root cause conclusions (e.g., pipetting error, analyst variation), delayed investigations, and lack of comprehensive production reviews or CAPAs. Approximately 55 of 78 OOS results from May 2019 to May 2021 were inappropriately invalidated. 2. **Failure to Submit NDA Field Alert Reports (FARs) (21 CFR § 314.81(b)(1)(i) and (ii)):** PDI did not submit FARs for distributed batches 120001