FDA Inspection
Dr. Mahendra Sanapati, MDDr. Mahendra Sanapati, MD – FDA Inspection, Sep 18, 2015
Record Details
This FDA Inspection record concerns Dr. Mahendra Sanapati, MD, with an inspection on September 18, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Dr. Mahendra Sanapati, MD
- Inspection Date
- September 18, 2015
- Product Type
- Devices
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ID · fba58060-1173-4082-b4c8-ff6b419505d4
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 942634
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 812.100Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.140(a)(3)(ii)Investigator records of relevant observations inadequate
- 21 CFR 812.140(a)(2)(i)Investigator device accountability inadequate
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Other FDA inspections of Dr. Mahendra Sanapati, MD
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 6, 2014 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
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