FDA Inspection 625989 — Carter BloodCare - Tyler
The FDA completed an inspection of Carter BloodCare - Tyler on October 20, 2009 in Tyler, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 20, 2009
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Tyler, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 61 | 21 CFR 606.60(a) | Provide proper equipment to meet requirements |
| 98 | 21 CFR 606.100(c) | Thorough investigations |