FDA Inspection
Zimmer Biomet CMF and Thoracic LLCZimmer Biomet CMF and Thoracic LLC – FDA Inspection, Sep 1, 2017
Record Details
This FDA Inspection record concerns Zimmer Biomet CMF and Thoracic LLC, with an inspection on September 1, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e64816ed-aed4-40f9-a41a-e87ea09a2b07
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1024178
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Zimmer Biomet CMF and Thoracic LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 4, 2025 | VAI | Florida District Office | Compliance: Medical Devices |
| May 24, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 30, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 17, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Zimmer Biomet CMF and Thoracic LLC
- FDA Inspection 1262841 - 2025-03-04
- FDA Inspection 1053122 - 2018-05-24
- FDA Inspection 947565 - 2015-10-30
- FDA Inspection 764538 - 2012-01-17
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