FDA Inspection 860326 — Acorda Therapeutics, Inc.
The FDA completed an inspection of Acorda Therapeutics, Inc. on Dec 19, 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 19, 2013
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Pearl River, NY (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 6706 | 21 CFR 310.305(c)(1)(i) | Late submission |
| 6728 | 21 CFR 314.80(b) | Failure to review ADE information |