FDA Inspection
Breckenridge Pharmaceutical, IncBreckenridge Pharmaceutical, Inc – FDA Inspection, Feb 21, 2017
Record Details
This FDA Inspection record concerns Breckenridge Pharmaceutical, Inc, with an inspection on February 21, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Christopher Janik (FDA Associated Person)
- Dien N. Nguyen (Issuing Officer)
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ID · 9f0c813f-ccc6-4850-9510-0ebb41e248c9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1003361
- FDA center
- Human Drugs
- Project area
- Postmarket Surv. and Epidemiology
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
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Other FDA inspections of Breckenridge Pharmaceutical, Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 5, 2024 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| January 29, 2019 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| September 25, 2014 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| May 17, 2011 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Breckenridge Pharmaceutical, Inc
- FDA Inspection 1227134 - 2024-01-05
- FDA Inspection 1082461 - 2019-01-29
- FDA Inspection 898018 - 2014-09-25
- FDA Inspection 727340 - 2011-05-17
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