FDA Inspection 995345 — Commerce Evolution, Inc.
The FDA completed an inspection of Commerce Evolution, Inc. on Nov 4, 2016 in Miami, FL. 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). 7 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 4, 2016
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12415 | 21 CFR 1271.260(e) | Temperature limits |
| 12416 | 21 CFR 1271.260(e) | Storage temperatures recorded, maintained |
| 12421 | 21 CFR 1271.265(a) | Acceptance criteria designed to prevent CD |
| 12429 | 21 CFR 1271.265(d) | Shipping conditions appropriate |
| 12433 | 21 CFR 1271.265(f) | Return to inventory--procedures |
| 12457 | 21 CFR 1271.320(a) | Procedures re complaints |