FDA Inspection 1061834 — LifeSouth Community Blood Centers, Inc
The FDA completed an inspection of LifeSouth Community Blood Centers, Inc on Jul 24, 2018 in Gainesville, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 12 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 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 |