FDA Inspection 1096052 — NIH Donor Center at Fishers Lane
The FDA completed an inspection of NIH Donor Center at Fishers Lane on July 11, 2019 in Rockville, MD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 11, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Rockville, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18093 | 21 CFR 630.10(g)(1) | Proof Of Identity |
| 18134 | 21 CFR 640.21(g) | Informed consent |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |