FDA WARNING_LETTER - ANJI ZHENGBANG MEDICAL INSTRUMENT CO, LTD - July 04, 2013

On July 1-4, 2013, an FDA inspection of Anji Zheng Bang Medical Instruments Co., Ltd. in Anji, China, revealed that their catheter insertion kits, blood piercing devices, and surgical forceps are adulterated. The firm's manufacturing, packing, storage, or installation methods and controls do not conform to the Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a)):** Procedures lacked requirements for documenting nonconformance investigations, verifying effectiveness of changes, and specifying external auditor qualifications for initiating CAPAs. CAPA records also showed inconsistent review/closure by the Quality Manager instead of the Management Representative, and inadequate documentation of effectiveness and effective dates. 2. **Failure to validate processes (21 CFR 820.75(a)):** No documentation of process validation or revalidation for manufacturing equipment for blood piercing devices, 9-inch forceps, and catheter insertion kits, or after specification changes for the blood piercing device. 3. **Failure to translate design into production specifications (21 CFR 820.30(h)):** No procedures to transfer customer design specifications into production for the blood piercing device, 9-inch forceps, and catheter insertion kit. 4. **Failure to control environmental conditions (2