FDA Inspection 810516 — Ascent Pharmaceuticals Inc
The FDA completed an inspection of Ascent Pharmaceuticals Inc on December 6, 2012 in Central Islip, NY. 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
- December 6, 2012
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Central Islip, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 3557 | 21 CFR 211.52 | Washing and toilet facilities are deficient |
| 4345 | 21 CFR 211.160(b)(1) | Samples (various types) representative, identified properly |