708410
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 10, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Charleston, SC (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 155 | 21 CFR 606.160(b) | Required records |
| 4425 | 21 CFR 606.60(a) | Equipment observed, standardized, calibrated |
| 54 | 21 CFR 606.40(d)(2) | Provide adequate disposal of blood & blood components |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 78 | 21 CFR 606.100(c) | Record review prior to release |
| 98 | 21 CFR 606.100(c) | Thorough investigations |