FDA Inspection 744113 — LifeSouth Community Blood Centers Shoals Region
The FDA completed an inspection of LifeSouth Community Blood Centers Shoals Region on August 31, 2011 in Florence, AL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 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 |