FDA Inspection
Weill Cornell Medical Center RDRCWeill Cornell Medical Center RDRC – FDA Inspection, Sep 29, 2016
Record Details
This FDA Inspection record concerns Weill Cornell Medical Center RDRC, with an inspection on September 29, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 29, 2016
- Product Type
- Drugs
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ID · 88b74798-83a6-4df0-8c6b-5162d67211f5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 986819
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 361.1(f)(2)Label - For research use
- 21 CFR 361.1(f)(1)Packaging, labeling - Rx only
- 21 CFR 361.1(c)(2)Numerical votes not in the minutes of any RDRC meetings
- 21 CFR 361.1(c)(2)RDRC has not kept minutes of its meetings
- 21 CFR 361.1(c)(3)Annual reports not submitted to FDA
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