FDA Inspection
Sandeep Bagla, MDSandeep Bagla, MD – FDA Inspection, Jul 31, 2013
Record Details
This FDA Inspection record concerns Sandeep Bagla, MD, with an inspection on July 31, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sandeep Bagla, MD
- Inspection Date
- July 31, 2013
- Product Type
- Devices
View Company Profile
ID · b325a517-8117-4111-975a-fa4b16fd2a0a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 842314
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
7- 21 CFR 812.150(a)(1)Investigator report of unanticipated adverse effects
- 21 CFR 812.20(a)(1)Did not submit IDE application to FDA
- 21 CFR 812.110(b)Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.40Sponsors" general responsibilities
- 21 CFR 812.150(a)(4)Investigator non-emergency safety or soundness changes
- 21 CFR 812.110(a)Subject participation prior to study approval
- 21 CFR 50.25(a)(1)Procedures, identification of those which were experimental
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