1061834
LifeSouth Community Blood Centers, Inc — FEI 3003707120
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 24, 2018
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Gainesville, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 21297 | 21 CFR 211.186(a) | Master production and control records, procedure |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4360 | 21 CFR 211.170(b) | Reserve drug product sample quantity - all tests |
| 9089 | 21 CFR 600.14(c) | When to report |
| 9461 | 21 CFR 610.60 | Package label - small containers |