FDA Inspection
Acorda Therapeutics, Inc.Acorda Therapeutics, Inc. – FDA Inspection, Feb 26, 2009
Record Details
This FDA Inspection record concerns Acorda Therapeutics, Inc., with an inspection on February 26, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Acorda Therapeutics, Inc.
- Inspection Date
- February 26, 2009
- Product Type
- Drugs
View Company Profile
ID · b591d8d1-e012-4460-a7b6-ce5b4f815ab7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 564405
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 314.81(b)(2)Timely submission
- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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.