# FDA 483 - Biomet, Inc. - July 15, 2008

Source: https://www.globalkeysolutions.net/records/483/biomet-inc/901c3c73-b66f-4268-b218-66633d64978b

> FDA 483 for Biomet, Inc. on July 15, 2008. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biomet, Inc.
- Inspection Date: 2008-07-15
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Biomet, Inc. in Warsaw, IN, was cited for significant deficiencies in its role as a sponsor of investigational studies. The inspection revealed widespread issues including inadequate monitoring of clinical sites, investigator non-compliance with study protocols and regulations, and failures in obtaining proper IRB approvals for study initiation and plan modifications. These observations highlight a critical lack of oversight in clinical investigations and data integrity.

## Related Documents

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- [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 - 2020-01-30](https://www.globalkeysolutions.net/records/483/biomet-inc/b32d67d4-c5a1-4e72-922e-008892846767)

## Related Officers

- [U.S. Food and Drug Administration](https://www.globalkeysolutions.net/people/myra-k-casey/a2fae714-2ba3-4c60-9f54-990fc7b169c9)

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