# FDA 483 - Biomet, Inc. - January 30, 2020

Source: https://www.globalkeysolutions.net/records/483/biomet-inc/b32d67d4-c5a1-4e72-922e-008892846767

> FDA 483 for Biomet, Inc. on January 30, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biomet, Inc.
- Inspection Date: 2020-01-30
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Zimmer Biomet, Inc. in Warsaw, IN, revealed significant deficiencies in their quality system, particularly concerning process validation, corrective and preventive actions (CAPA), and environmental controls for medical devices. The firm failed to adequately validate sterilization and cleaning processes, experienced delays in addressing a Class II recall related to elevated endotoxins, and exhibited inadequate design control and nonconforming product procedures. Several observations were repeats from a previous 2018 inspection, indicating persistent issues.

## Related Documents

- [483 - 2018-04-24](https://www.globalkeysolutions.net/records/483/biomet-inc/f7299370-0bcf-4150-a52c-646f311b7c61)
- [483 - 2018-04-24](https://www.globalkeysolutions.net/records/483/biomet-inc/4316d727-9808-4868-8a70-c78a4b850a55)
- [483_RESPONSE - 2016-11-22](https://www.globalkeysolutions.net/records/483_response/biomet-inc/159e464e-90ad-4ff9-a4d7-e4c8086af1be)
- [483 - 2017-10-16](https://www.globalkeysolutions.net/records/483/biomet-inc/1d5dda7f-de97-40ba-b321-1dc174809dfc)
- [483 - 2016-11-22](https://www.globalkeysolutions.net/records/483/biomet-inc/67bb09d3-3d24-4e59-98e2-2f005eea6d78)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/dennis-r-hock/f13e2db1-b808-466d-a974-e5af2d5dfdb0)
- [Suyong Jin](https://www.globalkeysolutions.net/people/suyong-jin/59a29230-bbdd-4deb-8839-2aaaecdd40aa)
- [Investigator ](https://www.globalkeysolutions.net/people/benjamin-j-dastoli/688c2ad7-f7ac-47eb-8ca2-4efcd221f636)
- [Medical Device Senior Operations Officer at FDA](https://www.globalkeysolutions.net/people/thomas-a-peter/48a36892-cc03-42bb-8960-978d18f2147a)

Company: https://www.globalkeysolutions.net/companies/biomet-inc/ca22677e-55e1-4eeb-a8a2-beabeef1c3ad

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0