1290064
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 23, 2025
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- San Rafael, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1927 | 21 CFR 211.166(b) | Accelerated stability studies |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3591 | 21 CFR 211.110(b) | In-process materials specifications |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 4315 | 21 CFR 211.84(d)(2) | Testing Each Component for Conformity with Specs |
| 4406 | 21 CFR 211.194(a)(2) | Suitability of testing methods verified |