FDA Inspection 744113 — LifeSouth Community Blood Centers Shoals Region
The FDA completed an inspection of LifeSouth Community Blood Centers Shoals Region on Aug 31, 2011 in Florence, AL. 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
- Aug 31, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Florence, AL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9044 | 21 CFR 600.10(b) | Personnel capabilities |
| 94 | 21 CFR 606.100(b)(15) | Schedules and procedures for equipment & calibration |
| 98 | 21 CFR 606.100(c) | Thorough investigations |