FDA Inspection
Brigham and Women's Hospital RDRCBrigham and Women's Hospital RDRC – FDA Inspection, Sep 19, 2019
Record Details
This FDA Inspection record concerns Brigham and Women's Hospital RDRC, with an inspection on September 19, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 06a20886-73e1-4024-a4b9-966a2452f908
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1102461
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 361.1(f)(12)Label - Inactive ingredient, name
- 21 CFR 361.1(f)(2)Label - For research use
- 21 CFR 361.1(f)(1)Packaging, labeling - Rx only
- 21 CFR 361.1(f)(11)Label - Parenteral drug, sterile
- 21 CFR 361.1(c)(2)Numerical votes not in the minutes of any RDRC meetings
- 21 CFR 361.1(c)(2)Signatures of RDRC Chairman
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