FDA Inspection 778165 — Almac Clinical Services, LLC.
The FDA completed an inspection of Almac Clinical Services, LLC. on Apr 19, 2012 in Durham, NC. 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 19, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Durham, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3641 | 21 CFR 211.204 | Record information inclusions |