FDA Inspection 812545 — Acorda Therapeutics, Inc.
The FDA completed an inspection of Acorda Therapeutics, Inc. on Jan 16, 2013 in Pearl River, NY. 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 16, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Postmarket Surv. and Epidemiology
- Location
- Pearl River, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 6730 | 21 CFR 314.80(b) | Failure to develop written procedures |
| 6732 | 21 CFR 314.80(c)(1)(i) | Late submission of 15-day report |
| 6735 | 21 CFR 314.80(c)(1)(ii) | Failure to investigate serious, unexpected events |
| 6823 | 21 CFR 314.80(c) | Failure by applicant to report ADE |
| 6831 | 21 CFR 314.80(c)(2) | Late submission of quarterly safety reports |
| 8907 | 21 CFR 314.81(b)(1)(ii) | Contamination, chemical or physical change, deterioration |