FDA Inspection 759247 — Forest Pharmaceuticals Inc
The FDA completed an inspection of Forest Pharmaceuticals Inc on Dec 2, 2011 in Earth City, MO. 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 2, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Earth City, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 4353 | 21 CFR 211.160(b)(4) | Instruments, apparatus, et. al. not meeting specs |
| 6732 | 21 CFR 314.80(c)(1)(i) | Late submission of 15-day report |