FDA Inspection
Blue Cross Laboratories, IncBlue Cross Laboratories, Inc – FDA Inspection, Sep 7, 2018
Record Details
This FDA Inspection record concerns Blue Cross Laboratories, Inc, with an inspection on September 7, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · bafa82f7-fefd-4a24-8e6f-38694eed9bd1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1065079
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.150(b)Recall facilitation
- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.170(b)(1)Retention time of reserve samples, in general
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Other FDA inspections of Blue Cross Laboratories, Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 17, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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