Warning letter
Acorda Therapeutics Inc.: warning letter of May 10, 2012
FDA warning letter 232754 · New York District Office
Key facts
| Reference number | 232754 |
|---|---|
| Company | Acorda Therapeutics Inc. |
| Subject | Adverse Drug Experience (ADE) |
| Issue date | May 10, 2012 |
| Posted date | May 10, 2012 |
| Issuing office | New York District Office |
| Product type | Drugs |
| CFR sections cited | 314.80, 314.80(c)(1)(i), 314.80(c)(1)(ii), 314.80(b), 314.80(c)(2)(i), 314.80(i) |
| Inspection city | Pearl River |
| Inspection ZIP | 10965 |
| Inspection start date | Aug 15, 2011 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: