FDA WARNING_LETTER - PDS Manufacturing, Inc. - August 27, 2008

On August 25-27, 2008, an FDA inspection of PDS Manufacturing, Inc. in Southlake, Texas, revealed that their cryosurgical system devices were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Key violations included: 1. **Inadequate Quality System (21 CFR § 820.20):** Failure to establish a quality policy, appoint a management representative, implement internal quality audit procedures, and conduct management reviews. 2. **Insufficient Corrective and Preventive Action (CAPA) Procedures (21 CFR § 820.100(a)):** Failure to investigate nonconformities (e.g., 115 devices with cooling issues/replaced global board chips, 19 devices with replaced seals), identify and implement corrective actions, and ensure information dissemination. Engineering Change Notices (ECN) and Instruction Change Notices (ICN) were not properly signed or effectiveness checks documented. 3. **Lack of Product Acceptance Status Documentation (21 CFR § 820.86):** Failure to identify, document, and approve the acceptance status of products, specifically 25 reworked devices with diode assembly errors. 4. **Inadequate R