FDA Inspection 861316 — Tri-State Biologics Inc.
The FDA completed an inspection of Tri-State Biologics Inc. on January 7, 2014 in Secaucus, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 7, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Secaucus, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12417 | 21 CFR 1271.260(e) | Periodic review of temperatures |
| 12433 | 21 CFR 1271.265(f) | Return to inventory--procedures |
| 12452 | 21 CFR 1271.290(d) | Recording I.D. code and type of HCT/P |
| 12453 | 21 CFR 1271.290(e) | Documenting disposition of each HCT/P |