FDA Inspection
BR SASBR SAS – FDA Inspection, Sep 22, 2017
Record Details
This FDA Inspection record concerns BR SAS, with an inspection on September 22, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 9940d6a7-5b33-4f13-b653-f3fdada23c20
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1026500
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.192No written record of investigation
- 21 CFR 211.182Written records kept in individual logs
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