1177681
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 17, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Edison, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1886 | 21 CFR 211.165(c) | Sampling and testing plans not described |
| 2023 | 21 CFR 211.188(b)(11) | Identification of Persons Performing Significant Steps |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |