FDA Inspection 951965 — Elite Orthopedics, LLC
The FDA completed an inspection of Elite Orthopedics, LLC on Dec 4, 2015 in Chesterfield, MO. 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
- Dec 4, 2015
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Chesterfield, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12309 | 21 CFR 1271.160(a) | Program is appropriate for the HCT/Ps |
| 12416 | 21 CFR 1271.260(e) | Storage temperatures recorded, maintained |