FDA WARNING_LETTER - Tianjin Hanaco Xingda Medical Co., Ltd. - August 16, 2012

On December 5, 2012, the FDA issued a Warning Letter to Tianjin Hanaco Xingda Medical Co., Ltd. following an inspection from August 13-16, 2012, which found their intravenous (IV) administration sets to be adulterated. The firm's manufacturing, packing, storage, or installation methods and controls did not conform to the Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Process Validation (21 CFR 820.75(a)):** Failure to adequately document process validation activities, including IQ, OQ, and equipment used in testing, and lack of validation for retesting practices. 2. **Corrective and Preventive Actions (CAPA) (21 CFR 820.100(a)(5)):** CAPA procedures did not include requirements for implementing and recording changes, and implementation was not recorded in several CAPA files. 3. **Complaint Files (21 CFR 820.198(e)):** Records of investigation for IV tubing damage did not include investigation results. 4. **Finished Device Acceptance (21 CFR 820.80(d)):** Finished acceptance testing procedures for standard IV administration sets lacked complete criteria for specific testing. 5. **Calibration (21 CFR 820.72