FDA Inspection 1099613 — LifeShare Blood Center
The FDA completed an inspection of LifeShare Blood Center on Aug 9, 2019 in Shreveport, LA. 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
- Aug 9, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Shreveport, LA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12202 | 21 CFR 606.170(a) | Adverse Reaction - Investigations |
| 18093 | 21 CFR 630.10(g)(1) | Proof Of Identity |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9241 | 21 CFR 630.40(a) | Supplemental results |