FDA Inspection 897638 — LifeSouth Community Blood Centers, Inc.
The FDA completed an inspection of LifeSouth Community Blood Centers, Inc. on Sep 30, 2014 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). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 30, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Gainesville, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 155 | 21 CFR 606.160(b) | Required records |
| 255 | 21 CFR 640.31 | Donor eligibility |
| 98 | 21 CFR 606.100(c) | Thorough investigations |