1119393
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 2, 2020
- Fiscal Year
- 2020
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Rockville, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12241 | 21 CFR 1271.55(b)(4) | Reasons for ineligibility on summary |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12493 | 21 CFR 1271.90(c) | Eligibility not required--warning labels |