1070999
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 5, 2018
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Compton, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 3607 | 21 CFR 211.160(b)(2) | Acceptance of in-process materials |