FDA Inspection
Supernus Pharmaceuticals, Inc.Supernus Pharmaceuticals, Inc. – FDA Inspection, Feb 3, 2017
Record Details
This FDA Inspection record concerns Supernus Pharmaceuticals, Inc., with an inspection on February 3, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · c2d27c0d-ba92-4fea-b2c1-e2ad08305875
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1010922
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 314.80(c)(2)Late submission of quarterly safety reports
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Other FDA inspections of Supernus Pharmaceuticals, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| July 31, 2025 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 10, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 10, 2019 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| February 23, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 19, 2014 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Supernus Pharmaceuticals, Inc.
- FDA Inspection 1280332 - 2025-07-31
- FDA Inspection 1109126 - 2019-10-10
- FDA Inspection 1098819 - 2019-07-10
- FDA Inspection 915034 - 2015-02-23
- FDA Inspection 888135 - 2014-06-19
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