1179318
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 19, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Carlsbad, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |