FDA Inspection 721339 — TriRx Huntsville Pharmaceutical Services, LLC
The FDA completed an inspection of TriRx Huntsville Pharmaceutical Services, LLC on April 14, 2011 in Huntsville, AL. 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 14, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Huntsville, AL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |