FDA Inspection 1027008 — Hackensack University Medical Center
The FDA completed an inspection of Hackensack University Medical Center on September 29, 2017 in Hackensack, 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
- September 29, 2017
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Hackensack, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12399 | 21 CFR 1271.230(a) | Process validation procedures |
| 12457 | 21 CFR 1271.320(a) | Procedures re complaints |