FDA Inspection
Carlos H. Montenegro, MDCarlos H. Montenegro, MD – FDA Inspection, Nov 22, 2013
Record Details
This FDA Inspection record concerns Carlos H. Montenegro, MD, with an inspection on November 22, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Carlos H. Montenegro, MD
- Inspection Date
- November 22, 2013
- Product Type
- Drugs
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ID · 4a8ec4b5-28cc-4ce3-89d8-fb60176ea732
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 857330
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 312.64(b)Safety reports
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