FDA Inspection
Brio Pharmaceuticals IncBrio Pharmaceuticals Inc – FDA Inspection, Jul 11, 2019
Record Details
This FDA Inspection record concerns Brio Pharmaceuticals Inc, with an inspection on July 11, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · e7bb136f-ec6b-4d21-82ff-c94f3b0fb2de
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1096432
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.111Establishment of time limitations
- 21 CFR 211.166(a)(2)Stability sample storage conditions described
- 21 CFR 211.188(a)Accurate reproduction
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.46(b)Equipment for Environmental Control
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Other FDA inspections of Brio Pharmaceuticals Inc
10| Date | Classification | Office | Project area |
|---|---|---|---|
| June 19, 2026 | Not classified | Dallas District Office | |
| February 27, 2026 | VAI | Dallas District Office | Drug Quality Assurance |
| October 3, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 26, 2017 | Not classified | Dallas District Office | Drug Quality Assurance |
| June 1, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Brio Pharmaceuticals Inc
- FDA Inspection 1323564 - 2026-06-19
- FDA Inspection 1304746 - 2026-02-27
- FDA Inspection 1067624 - 2018-10-03
- FDA Inspection 1011466 - 2017-04-26
- FDA Inspection 929358 - 2015-06-01
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