FDA Inspection
Bluefield Associates, Inc.Bluefield Associates, Inc. – FDA Inspection, May 10, 2017
Record Details
This FDA Inspection record concerns Bluefield Associates, Inc., with an inspection on May 10, 2017, issued by the Los Angeles District Office, covering human drugs.
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ID · 90018fd1-18db-493a-ad22-9b4e31529f11
Inspection Facts
- Inspection number
- 1011596
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.89Quarantine of Rejected Components et. al.
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Other FDA inspections of Bluefield Associates, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| September 17, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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