FDA Inspection 798651 — New Jersey Organ and Tissue Sharing Network Inc.
The FDA completed an inspection of New Jersey Organ and Tissue Sharing Network Inc. on September 14, 2012 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). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 14, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- New Providence, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12329 | 21 CFR 1271.160(d) | Documentation/approval prior to implementation |