FDA Inspection 912469 — Wright Medical Technology, Inc. - District Service Center - St. Louis
The FDA completed an inspection of Wright Medical Technology, Inc. - District Service Center - St. Louis on February 4, 2015 in Fenton, MO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 4, 2015
- Fiscal Year
- 2015
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Fenton, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12322 | 21 CFR 1271.160(b)(4) | Training of personnel |
| 12325 | 21 CFR 1271.160(b)(6) | Deviations--evaluation, cause, corrective action |
| 12339 | 21 CFR 1271.180(c) | Availability of procedures |
| 12416 | 21 CFR 1271.260(e) | Storage temperatures recorded, maintained |
| 12452 | 21 CFR 1271.290(d) | Recording I.D. code and type of HCT/P |