FDA Inspection
Bluefield Associates, Inc.Bluefield Associates, Inc. – FDA Inspection, Sep 17, 2009
Record Details
This FDA Inspection record concerns Bluefield Associates, Inc., with an inspection on September 17, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Bluefield Associates, Inc.
- Inspection Date
- September 17, 2009
- Product Type
- Drugs
View Company Profile
ID · 968e3934-b30a-4934-b041-4d394926ce2d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 610615
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.48(a)Plumbing System Defects
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
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Other FDA inspections of Bluefield Associates, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 10, 2017 | Not classified | Los Angeles District Office | Drug Quality Assurance |
| March 7, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 3, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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