FDA Inspection
Javier O. Morales Ramirez, MDJavier O. Morales Ramirez, MD – FDA Inspection, May 22, 2009
Record Details
This FDA Inspection record concerns Javier O. Morales Ramirez, MD, with an inspection on May 22, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- May 22, 2009
- Product Type
- Drugs
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ID · 755e67db-8e52-4d61-b6bb-0f5ece5c8efb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 584551
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.60Informed consent
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 312.62(c)Record retention
- 21 CFR 312.62(a)Unused drug disposition (investigator)
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