FDA Inspection
ZimVie US Corp LLCZimVie US Corp LLC – FDA Inspection, Aug 2, 2013
Record Details
This FDA Inspection record concerns ZimVie US Corp LLC, with an inspection on August 2, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ZimVie US Corp LLC
- Inspection Date
- August 2, 2013
- Product Type
- Devices
View Company Profile
ID · 9d67d703-9d64-40c2-a0ca-60a91e8e08f9
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 843868
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 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 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.30(h)Incorrect translation to production specifications
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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 6, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: 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 890687 - 2014-08-06
- FDA Inspection 788665 - 2012-06-15
- FDA Inspection 579982 - 2009-05-01
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