FDA Inspection 559806 — Louisiana Coagulation Laboratory Inc
The FDA completed an inspection of Louisiana Coagulation Laboratory Inc on Jan 6, 2009 in Covington, 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). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 6, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Covington, LA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 155 | 21 CFR 606.160(b) | Required records |
| 78 | 21 CFR 606.100(c) | Record review prior to release |
| 89 | 21 CFR 606.100(b)(10) | Controlling storage temperatures |
| 98 | 21 CFR 606.100(c) | Thorough investigations |