FDA Inspection
Yudhishtra Markan, MDYudhishtra Markan, MD – FDA Inspection, Sep 9, 2015
Record Details
This FDA Inspection record concerns Yudhishtra Markan, MD, with an inspection on September 9, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Yudhishtra Markan, MD
- Inspection Date
- September 9, 2015
- Product Type
- Drugs
View Company Profile
ID · 95750fb6-f037-4bb5-828e-2009caab597e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 939845
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 56.104(c)Emergency use and IRB approval
- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 312.62(a)Accountability records
- 21 CFR 312.62(c)Record retention
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