FDA Inspection 1163565 — National Genetics Institute
The FDA completed an inspection of National Genetics Institute on March 2, 2022 in Los Angeles, CA. 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
- March 2, 2022
- Fiscal Year
- 2022
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Los Angeles, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14710 | 21 CFR 820.150 | Lack of or inadequate procedures for storage. |
| 3453 | 21 CFR 601.12(c) | Moderate changes to an approved application |
| 77 | 21 CFR 606.100(b) | Written SOPs available for use by personnel |