FDA Inspection
Saibal Kar, MDSaibal Kar, MD – FDA Inspection, Oct 20, 2017
Record Details
This FDA Inspection record concerns Saibal Kar, MD, with an inspection on October 20, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Mark W. Babbitt (Issuing Officer)
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ID · a1e784f9-a419-424e-893c-f94f10760798
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1029319
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 812.110(b)Investigator non-compliance with agreement/plan/regulations
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Other FDA inspections of Saibal Kar, MD
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 8, 2018 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| July 20, 2013 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| February 14, 2013 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Saibal Kar, MD
- FDA Inspection 1045010 - 2018-03-08
- FDA Inspection 844644 - 2013-07-20
- FDA Inspection 818442 - 2013-02-14
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