FDA Inspection 927507 — Zimmer Trabecular Metal Technology, Inc.
The FDA completed an inspection of Zimmer Trabecular Metal Technology, Inc. on May 11, 2015 in Parsippany, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 11, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Parsippany, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |