FDA Inspection 1279450 — Almac Pharma Services LLC
The FDA completed an inspection of Almac Pharma Services LLC on Aug 22, 2025 in Audubon, PA. 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 22, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Audubon, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3594 | 21 CFR 211.110(d) | Rejected in-process materials not quarantined |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |