FDA Inspection 973469 — Zimmer Surgical Inc
The FDA completed an inspection of Zimmer Surgical Inc on May 23, 2016 in Dover, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 23, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Dover, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 3696 | 21 CFR 820.100(b) | Documentation |