FDA Inspection 608489 — TriRx Huntsville Pharmaceutical Services, LLC
The FDA completed an inspection of TriRx Huntsville Pharmaceutical Services, LLC on Aug 21, 2009 in Huntsville, AL. 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 21, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Huntsville, AL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1219 | 21 CFR 211.67(b)(2) | Cleaning SOPs/schedules |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |