FDA Inspection
Blue Cross Laboratories, IncBlue Cross Laboratories, Inc – FDA Inspection, Sep 17, 2015
Record Details
This FDA Inspection record concerns Blue Cross Laboratories, Inc, with an inspection on September 17, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Blue Cross Laboratories, Inc
- Inspection Date
- September 17, 2015
- Product Type
- Drugs
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ID · 00048284-fe83-4685-b903-305730a5e53e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 943005
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.84(d)(2)Component written specification
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Blue Cross Laboratories, Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 7, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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