FDA Inspection 865719 — Zimmer, Inc.
The FDA completed an inspection of Zimmer, Inc. on February 7, 2014 in Warsaw, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 7, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Warsaw, IN (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 2949 | 21 CFR 812.46(a) | Sponsor securing investigator compliance |
| 7388 | 21 CFR 50.25(a)(2) | Reasonably foreseeable risks or discomforts |