FDA Inspection
Blairex Laboratories, IncBlairex Laboratories, Inc – FDA Inspection, Oct 18, 2010
Record Details
This FDA Inspection record concerns Blairex Laboratories, Inc, with an inspection on October 18, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Blairex Laboratories, Inc
- Inspection Date
- October 18, 2010
- Product Type
- Drugs
View Company Profile
ID · c76b73f7-ec0c-4e15-befe-c80c6fa80142
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 696872
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.198(b)(3)Determination not to conduct investigation of complaint
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.150Written distribution procedure
- 21 CFR 211.198(b)(2)Written record of complaint to include findings, follow-up
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Other FDA inspections of Blairex Laboratories, Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 12, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 26, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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