FDA Inspection
Braintree, A part of SEBELA PharmaceuticalsBraintree, A part of SEBELA Pharmaceuticals – FDA Inspection, Jan 21, 2011
Record Details
This FDA Inspection record concerns Braintree, A part of SEBELA Pharmaceuticals, with an inspection on January 21, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- January 21, 2011
- Product Type
- Drugs
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ID · 2980d372-45f6-4f29-bbd3-a2e16a160b75
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 707123
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.84(d)(2)Component written specification
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.84(c)(4)Top/Middle/Bottom container sampling
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
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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 |
| February 28, 2018 | VAI | 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 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 1042622 - 2018-02-28
- FDA Inspection 858979 - 2013-12-13
- FDA Inspection 814842 - 2013-01-14
- FDA Inspection 639857 - 2010-01-22
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