# FDA 483 - Biomet, Inc. - November 09, 2023

Source: https://www.keypedia.com/records/483/biomet-inc/f9ffe056-57aa-4873-ab11-bf7a5b33aceb

> FDA 483 for Biomet, Inc. on November 09, 2023. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Biomet, Inc.
- Inspection Date: 2023-11-09
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Biomet, Inc. in Warsaw, IN, revealed inadequate procedures for process changes, specifically concerning bioburden monitoring for Juggerstich Meniscal Repair and Juggerloc devices. The firm failed to maintain proper bioburden monitoring after a product routing deletion, resulting in the distribution of nonconforming lots. This indicates a serious lapse in quality system controls for medical device manufacturing.

## Related Documents

- [483 - 2018-04-24](https://www.keypedia.com/records/483/biomet-inc/f7299370-0bcf-4150-a52c-646f311b7c61)
- [483 - 2018-04-24](https://www.keypedia.com/records/483/biomet-inc/4316d727-9808-4868-8a70-c78a4b850a55)
- [483_RESPONSE - 2016-11-22](https://www.keypedia.com/records/483_response/biomet-inc/159e464e-90ad-4ff9-a4d7-e4c8086af1be)
- [483 - 2017-10-16](https://www.keypedia.com/records/483/biomet-inc/1d5dda7f-de97-40ba-b321-1dc174809dfc)
- [483 - 2020-01-30](https://www.keypedia.com/records/483/biomet-inc/b32d67d4-c5a1-4e72-922e-008892846767)

## Related Officers

- [Melina L. Rodriguez-Upton](https://www.keypedia.com/people/melina-l-rodriguez-upton/0b540980-5708-4251-8ea6-6254375506f1)
- [David J. Gasparovich](https://www.keypedia.com/people/david-j-gasparovich/478888db-d4b3-481a-89f5-ee234a160f07)
- [ Investigator ](https://www.keypedia.com/people/suyang-qin/c32419c5-1b78-4014-9f94-cb7ab17dfe05)

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

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