FDA Inspection 636446 — New Jersey Organ and Tissue Sharing Network Inc.
The FDA completed an inspection of New Jersey Organ and Tissue Sharing Network Inc. on December 23, 2009 in New Providence, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 23, 2009
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- New Providence, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12412 | 21 CFR 1271.260(b) | Storage temperatures appropriate |
| 12416 | 21 CFR 1271.260(e) | Storage temperatures recorded, maintained |