FDA Inspection
Braintree, A part of SEBELA PharmaceuticalsBraintree, A part of SEBELA Pharmaceuticals – FDA Inspection, Feb 28, 2018
Record Details
This FDA Inspection record concerns Braintree, A part of SEBELA Pharmaceuticals, with an inspection on February 28, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 717fe323-8916-49e3-b346-16040875b8a5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1042622
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.198(b)(1)Complaint Record required information
- 21 CFR 211.84(c)(4)Composite sample top/middle/bottom
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Braintree, A part of SEBELA Pharmaceuticals
6| Date | Classification | Office | Project area |
|---|---|---|---|
| March 7, 2025 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 13, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 14, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 21, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 22, 2010 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Braintree, A part of SEBELA Pharmaceuticals
- FDA Inspection 1261728 - 2025-03-07
- FDA Inspection 858979 - 2013-12-13
- FDA Inspection 814842 - 2013-01-14
- FDA Inspection 707123 - 2011-01-21
- FDA Inspection 639857 - 2010-01-22
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