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

Source: https://www.keypedia.com/records/warning_letter/zhejiang-biomet-medical-products-co-ltd/1b5639ff-b626-42ca-8f1a-f55bcd85c62f

> FDA WARNING_LETTER for Zhejiang Biomet Medical Products Co. Ltd. on January 22, 2015. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Zhejiang Biomet Medical Products Co. Ltd.
- Inspection Date: 2015-01-22
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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.

## Related Officers

- [Barb Akers](https://www.keypedia.com/people/barb-akers/3f939028-56ec-4787-a009-0c9e6501c1fb)
- [Jan B. Welch](https://www.keypedia.com/people/jan-b-welch/65bfaf7c-7ce6-4c33-80bd-090efbf2eec5)

Company: https://www.keypedia.com/companies/zhejiang-biomet-medical-products-co-ltd/2a3dac11-2c0d-4a88-972a-15c03cc3e18d

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7