FDA Inspection
ZimVie US Corp LLCZimVie US Corp LLC – FDA Inspection, May 1, 2009
Record Details
This FDA Inspection record concerns ZimVie US Corp LLC, with an inspection on May 1, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ZimVie US Corp LLC
- Inspection Date
- May 1, 2009
- Product Type
- Devices
View Company Profile
ID · 8b84b034-7ee0-4fd9-93a7-ad3158cd5c3d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 579982
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.100(a)(4)CAPA verification/validation of corrective/preventive action
- 21 CFR 820.30(c)Incomplete, ambiguous, conflicting design requirements
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.198(e)(6)Results of investigation
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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 |
| 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 |
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 843868 - 2013-08-02
- FDA Inspection 788665 - 2012-06-15
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