FDA Inspection
ZIMMER ORTHOPEDIC MFG LTDZIMMER ORTHOPEDIC MFG LTD – FDA Inspection, Jul 27, 2017
Record Details
This FDA Inspection record concerns ZIMMER ORTHOPEDIC MFG LTD, with an inspection on July 27, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d19d6189-e685-4d05-a68c-a3076ada5a7f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1021428
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of ZIMMER ORTHOPEDIC MFG LTD
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 16, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 5, 2012 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
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