FDA Inspection 857399 — Wright Medical Technology Inc.,
The FDA completed an inspection of Wright Medical Technology Inc., on Nov 15, 2013 in Norwood, MA. 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). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 15, 2013
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Norwood, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12414 | 21 CFR 1271.260(d) | Corrective actions |
| 12431 | 21 CFR 1271.265(e) | Procedures and release criteria |