FDA Inspection
John HaysJohn Hays – FDA Inspection, Mar 22, 2019
Record Details
This FDA Inspection record concerns John Hays, with an inspection on March 22, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 9a8b20ea-d251-481f-b112-9c74dbdd1703
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1083947
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.60Informed consent
- 21 CFR 312.64(b)Safety reports
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