FDA Inspection
Indivior, Inc.Indivior, Inc. – FDA Inspection, Oct 19, 2017
Record Details
This FDA Inspection record concerns Indivior, Inc., with an inspection on October 19, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · c7122a94-6dba-4c9e-ad56-6e3330aed84a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1030039
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 312.50General responsibilities of sponsors
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Indivior, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| July 23, 2021 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| December 18, 2019 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| May 10, 2019 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| December 4, 2012 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| February 15, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Indivior, Inc.
- FDA Inspection 1149155 - 2021-07-23
- FDA Inspection 1115618 - 2019-12-18
- FDA Inspection 1091880 - 2019-05-10
- FDA Inspection 809099 - 2012-12-04
- FDA Inspection 767415 - 2012-02-15
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