FDA Inspection
Assertio Therapeutics, Inc.Assertio Therapeutics, Inc. – FDA Inspection, Nov 2, 2016
Record Details
This FDA Inspection record concerns Assertio Therapeutics, Inc., with an inspection on November 2, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · c0034c20-fea7-4ce7-86ba-e7c6a6ba6ccb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 991565
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Assertio Therapeutics, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 4, 2025 | Not classified | Chicago District Office | |
| November 9, 2022 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 22, 2022 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| March 26, 2021 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| May 25, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Assertio Therapeutics, Inc.
- FDA Inspection 1281169 - 2025-09-04
- FDA Inspection 1192639 - 2022-11-09
- FDA Inspection 1163048 - 2022-02-22
- FDA Inspection 1141337 - 2021-03-26
- FDA Inspection 662609 - 2010-05-25
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