FDA Inspection
B & G Labs, IncB & G Labs, Inc – FDA Inspection, Nov 7, 2014
Record Details
This FDA Inspection record concerns B & G Labs, Inc, with an inspection on November 7, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- B & G Labs, Inc
- Inspection Date
- November 7, 2014
- Product Type
- Drugs
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ID · 7fff3b01-0108-4d2f-8897-8c79a404788d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 903080
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.25(b)Supervisor Training/Education/Experience
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.111Establishment of time limitations
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Other FDA inspections of B & G Labs, Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 10, 2016 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| February 10, 2012 | VAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| November 24, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for B & G Labs, Inc
- FDA Inspection 967721 - 2016-02-10
- FDA Inspection 767080 - 2012-02-10
- FDA Inspection 629990 - 2009-11-24
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