FDA Inspection
James E Heubi MDJames E Heubi MD – FDA Inspection, May 7, 2014
Record Details
This FDA Inspection record concerns James E Heubi MD, with an inspection on May 7, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- James E Heubi MD
- Inspection Date
- May 7, 2014
- Product Type
- Drugs
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ID · 265a0d9b-c3c8-4106-9b7b-078ca539e6ee
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 883313
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
8- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.66Initial and continuing review
- 21 CFR 312.60Informed consent
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 312.50General responsibilities of sponsors
- 21 CFR 312.62(a)Accountability records
- 21 CFR 312.57(a)Records of receipt, shipment, disposition
- 21 CFR 312.53(b)Shipment to unauthorized persons
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