FDA WARNING_LETTER - Zhejiang Biomet Medical Products Co. Ltd. - January 22, 2015

On January 19-22, 2015, an FDA inspection of Zhejiang Biomet Medical Products Co., Ltd. in Jinhua City, China, revealed that the firm's orthopedic surgical instruments, classified as devices, were adulterated under 21 U.S.C. § 351(h). The manufacturing, packing, storage, or installation methods did not conform to the Quality System regulation (21 CFR Part 820).

Key violations included: 1. **Failure to identify actions to correct and prevent recurrence of nonconforming product (21 CFR 820.100(a)(3))**: For example, 1,051 "3.5 MM INSERTER CONNECTOR" pieces were shipped without meeting tensile strength requirements, leading to 45 tip fracture complaints. The firm's investigation and CAPA (CA-01097) were insufficient as they did not review other products for design transfer failures or investigate preventing torsional overloading. A retrospective review of other products is required. 2. **Failure to establish and maintain procedures for monitoring and control of process parameters for validated processes (21 CFR 820.75(b))**: Procedures for monitoring validated processes, including data to be monitored, control limits, and data analysis, were absent. A retrospective review of validated processes is required to ensure no nonconforming products were distributed.