FDA Inspection
Bluefield Associates, Inc.Bluefield Associates, Inc. – FDA Inspection, Mar 3, 2011
Record Details
This FDA Inspection record concerns Bluefield Associates, Inc., with an inspection on March 3, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Bluefield Associates, Inc.
- Inspection Date
- March 3, 2011
- Product Type
- Drugs
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ID · de375925-0093-457e-a455-00ef1482075c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 716610
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.166(b)Tentative expiration date
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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 |
| September 17, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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