FDA Inspection 793595 — Terrebonne General Health System
The FDA completed an inspection of Terrebonne General Health System on Aug 6, 2012 in Houma, 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
- Aug 6, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Houma, LA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9225 | 21 CFR 606.171 | Biological product deviation report |
| 9270 | 21 CFR 610.40(h)(2)(ii) | Labeling of reactive units, units from deferred donors |
| 98 | 21 CFR 606.100(c) | Thorough investigations |