1051991
Clinical Resolution Laboratory Inc. — FEI 3005727243
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 15, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Brea, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 1134 | 21 CFR 211.25(b) | Supervisor Training/Education/Experience |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1927 | 21 CFR 211.166(b) | Accelerated stability studies |
| 2569 | 21 CFR 211.198(b) | Maintenance of Complaint File |
| 3567 | 21 CFR 211.84(d)(2) | Component identification test |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |