FDA Inspection
Thomas S. Tooma, M.D.Thomas S. Tooma, M.D. – FDA Inspection, Jul 17, 2015
Record Details
This FDA Inspection record concerns Thomas S. Tooma, M.D., with an inspection on July 17, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Thomas S. Tooma, M.D.
- Inspection Date
- July 17, 2015
- Product Type
- Drugs
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ID · a9a8853a-593f-42f5-b0da-e77a4c367310
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 932433
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
9- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.59Records of unused drug disposition
- 21 CFR 312.53(c)(1)Investigator statement (FDA 1572)
- 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 50.55(f)Documentation of permission by parents or guardian
- 21 CFR 312.6(a)Required label statement
- 21 CFR 312.20(a)Failure to submit an IND
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