FDA Inspection
Acorda Therapeutics, Inc.Acorda Therapeutics, Inc. – FDA Inspection, Jan 16, 2013
Record Details
This FDA Inspection record concerns Acorda Therapeutics, Inc., with an inspection on January 16, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Acorda Therapeutics, Inc.
- Inspection Date
- January 16, 2013
- Product Type
- Drugs
View Company Profile
ID · 22597b33-daba-4d73-a6cd-eb95fdbfe6d7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 812545
- FDA center
- Human Drugs
- Project area
- Postmarket Surv. and Epidemiology
FDA Citations
6- 21 CFR 314.80(c)Failure by applicant to report ADE
- 21 CFR 314.80(c)(1)(ii)Failure to investigate serious, unexpected events
- 21 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deterioration
- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
- 21 CFR 314.80(c)(2)Late submission of quarterly safety reports
- 21 CFR 314.80(b)Failure to develop written procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Acorda Therapeutics, Inc.
10| Date | Classification | Office | Project area |
|---|---|---|---|
| August 18, 2020 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 19, 2019 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| January 18, 2019 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| February 29, 2016 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| August 25, 2014 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Acorda Therapeutics, Inc.
- FDA Inspection 1130049 - 2020-08-18
- FDA Inspection 1100682 - 2019-07-19
- FDA Inspection 1079179 - 2019-01-18
- FDA Inspection 975465 - 2016-02-29
- FDA Inspection 892026 - 2014-08-25
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.