FDA Inspection
Biomet UK Ltd.Biomet UK Ltd. – FDA Inspection, Nov 2, 2023
Record Details
This FDA Inspection record concerns Biomet UK Ltd., with an inspection on November 2, 2023, issued by the Office of Inspections and Investigations.
- Company
- Biomet UK Ltd.
- Inspection Date
- November 2, 2023
View Company Profile
ID · 43e3f384-0592-4baf-b59e-936e985736a6
Inspection Facts
- Inspection number
- 1222658
- FDA center
- Medical Devices & Rad Health
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Biomet UK Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 3, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 18, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 2, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Biomet UK Ltd.
- FDA Inspection 1021429 - 2017-08-03
- FDA Inspection 918189 - 2015-03-18
- FDA Inspection 596100 - 2009-07-02
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