FDA Inspection
Biomet UK Ltd.Biomet UK Ltd. – FDA Inspection, Aug 3, 2017
Record Details
This FDA Inspection record concerns Biomet UK Ltd., with an inspection on August 3, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b538dbaf-9862-45ce-ac1e-985b4db1db1f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1021429
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.184DHR content
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Other FDA inspections of Biomet UK Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 2, 2023 | Not classified | Office of Inspections and Investigations | |
| 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 1222658 - 2023-11-02
- FDA Inspection 918189 - 2015-03-18
- FDA Inspection 596100 - 2009-07-02
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