FDA Inspection
Juan Jose Linares, MDJuan Jose Linares, MD – FDA Inspection, Sep 20, 2019
Record Details
This FDA Inspection record concerns Juan Jose Linares, MD, with an inspection on September 20, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 678105a0-a99c-437f-a0fd-3955add03317
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1102339
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
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