FDA Inspection
Christian Gastelum, M.D.Christian Gastelum, M.D. – FDA Inspection, May 21, 2015
Record Details
This FDA Inspection record concerns Christian Gastelum, M.D., with an inspection on May 21, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Christian Gastelum, M.D.
- Inspection Date
- May 21, 2015
- Product Type
- Drugs
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ID · 9b5a5bc7-0464-4f77-b8d1-a250d8adc99a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 927084
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 50.20Consent not obtained, exceptions do not apply
- 21 CFR 312.62(a)Unused drug disposition (investigator)
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