FDA Inspection 859922 — Piedmont Augusta Transfusion Service
The FDA completed an inspection of Piedmont Augusta Transfusion Service on Dec 20, 2013 in Augusta, GA. 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). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 20, 2013
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Augusta, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12203 | 21 CFR 606.170(a) | Adverse Reaction- Reports of Investigations |
| 144 | 21 CFR 606.140(c) | Adequate identification and handling of test samples |
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 88 | 21 CFR 606.100(b)(9) | Written methods for investigating adverse reactions |