FDA Inspection
Braeburn Pharmaceuticals Inc.Braeburn Pharmaceuticals Inc. – FDA Inspection, Feb 8, 2018
Record Details
This FDA Inspection record concerns Braeburn Pharmaceuticals Inc., with an inspection on February 8, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · c22b2ae9-da18-413a-b9fd-d96e3f307e35
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1042533
- FDA center
- Human Drugs
- Project area
- Postmarket Surv. and Epidemiology
- Outcome
- Form 483 issued
FDA Citations
2- FDCA 505-1(f)(4)Failure to comply with REMS Implementation System
- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
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Other FDA inspections of Braeburn Pharmaceuticals Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 28, 2017 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Braeburn Pharmaceuticals Inc.
- FDA Inspection 1035711 - 2017-11-28
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