FDA Inspection
Brio Pharmaceuticals IncBrio Pharmaceuticals Inc – FDA Inspection, Apr 26, 2017
Record Details
This FDA Inspection record concerns Brio Pharmaceuticals Inc, with an inspection on April 26, 2017, issued by the Dallas District Office, covering human drugs.
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ID · fa735a23-bad8-4360-be86-c3c74fa85bd7
Inspection Facts
- Inspection number
- 1011466
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.180(e)(1)Review of representative number of batches
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.198(a)Complaint Handling Procedure
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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 |
| July 11, 2019 | VAI | Center for Drug Evaluation and Research | Generic Drug Evaluation |
| October 3, 2018 | VAI | Center for Drug Evaluation and Research | 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 1096432 - 2019-07-11
- FDA Inspection 1067624 - 2018-10-03
- FDA Inspection 929358 - 2015-06-01
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