FDA Inspection
Blairex Laboratories, IncBlairex Laboratories, Inc – FDA Inspection, Dec 12, 2013
Record Details
This FDA Inspection record concerns Blairex Laboratories, Inc, with an inspection on December 12, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Blairex Laboratories, Inc
- Inspection Date
- December 12, 2013
- Product Type
- Drugs
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ID · b38573d2-f5ae-4d0e-ae10-32b70d74fc81
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 858623
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
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Other FDA inspections of Blairex Laboratories, Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 26, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 18, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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