FDA Inspection 824106 — Wright Medical Technology Inc
The FDA completed an inspection of Wright Medical Technology Inc on March 21, 2013 in Arlington, TN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 21, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Arlington, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12332 | 21 CFR 1271.170(b) | Qualifications lacking |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12356 | 21 CFR 1271.195(a) | Adequate control, proper conditions |
| 12399 | 21 CFR 1271.230(a) | Process validation procedures |
| 12414 | 21 CFR 1271.260(d) | Corrective actions |
| 12416 | 21 CFR 1271.260(e) | Storage temperatures recorded, maintained |