FDA Inspection
Acorda Therapeutics, Inc.Acorda Therapeutics, Inc. – FDA Inspection, Sep 9, 2011
Record Details
This FDA Inspection record concerns Acorda Therapeutics, Inc., with an inspection on September 9, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Acorda Therapeutics, Inc.
- Inspection Date
- September 9, 2011
- Product Type
- Drugs
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ID · bc21c245-952e-45c0-ab6e-a9fbc9f76afb
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 739375
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
10- 21 CFR 314.80(c)Failure by applicant to report ADE
- 21 CFR 314.80(b)Failure to review ADE information
- 21 CFR 314.80(c)(1)(ii)Failure to investigate serious, unexpected events
- 21 CFR 314.80(e)Failure to report post-marketing study ADEs
- 21 CFR 314.80(c)(2)Failure to report non-alert ADEs
- 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(j)Failure to maintain records
- 21 CFR 314.80(b)Failure to develop written procedures
- 21 CFR 314.80(c)(1)(iii)Non-applicant reports to applicant
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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
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