FDA Inspection 985597 — Patheon Manufacturing Services LLC
The FDA completed an inspection of Patheon Manufacturing Services LLC on Dec 17, 2015 in Greenville, 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 17, 2015
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Greenville, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |