FDA Inspection
Dewan AsheeshDewan Asheesh – FDA Inspection, Mar 13, 2017
Record Details
This FDA Inspection record concerns Dewan Asheesh, with an inspection on March 13, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b029cae4-e79b-4a21-9f4e-130d3d6d949c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1006851
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 812.110(b)Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.140(a)(3)(i)Investigator records of informed consent inadequate
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