FDA Inspection
ZimVie US Corp LLCZimVie US Corp LLC – FDA Inspection, Aug 6, 2014
Record Details
This FDA Inspection record concerns ZimVie US Corp LLC, with an inspection on August 6, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ZimVie US Corp LLC
- Inspection Date
- August 6, 2014
- Product Type
- Devices
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ID · c2d9f63a-38f4-40e5-bc1d-974ffa167c4a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 890687
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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Other FDA inspections of ZimVie US Corp LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 25, 2018 | Not classified | Florida District Office | |
| July 11, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 2, 2013 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 15, 2012 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 1, 2009 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for ZimVie US Corp LLC
- FDA Inspection 1110361 - 2018-10-25
- FDA Inspection 1019545 - 2017-07-11
- FDA Inspection 843868 - 2013-08-02
- FDA Inspection 788665 - 2012-06-15
- FDA Inspection 579982 - 2009-05-01
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