FDA Inspection
University of Southern California (USC) Radioactive Drug Research Committee #36University of Southern California (USC) Radioactive Drug Research Committee #36 – FDA Inspection, Jul 25, 2018
Record Details
This FDA Inspection record concerns University of Southern California (USC) Radioactive Drug Research Committee #36, with an inspection on July 25, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- July 25, 2018
- Product Type
- Drugs
- People
- Angela Shepas (Company Rep)
- Richard M. Fejka (Issuing Officer)
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ID · 9cc9b5ec-bde5-4802-aeb9-2a7c790a21b6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1059930
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
2- 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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