FDA Inspection 564405 — Acorda Therapeutics, Inc.
The FDA completed an inspection of Acorda Therapeutics, Inc. on Feb 26, 2009 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 26, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Pearl River, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 8911 | 21 CFR 314.81(b)(1)(ii) | Failure to meet specifications |
| 8912 | 21 CFR 314.81(b)(2) | Timely submission |