FDA Inspection
Parikh, Dr ParagParikh, Dr Parag – FDA Inspection, Mar 1, 2012
Record Details
This FDA Inspection record concerns Parikh, Dr Parag, with an inspection on March 1, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Parikh, Dr Parag
- Inspection Date
- March 1, 2012
- Product Type
- Devices
View Company Profile
ID · b9f523e5-fdaf-4480-9708-c1596a5fb268
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 768692
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
6- 21 CFR 812.110(b)Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.43(c)No investigator agreement
- 21 CFR 312.50General responsibilities of sponsors
- 21 CFR 812.140(a)(2)(i)Investigator device accountability inadequate
- 21 CFR 812.150(b)(5)Sponsor progress reports for treatment IDE study
- 21 CFR 812.140(b)(3)Sponsor records of investigator agreements inadequate
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Parikh, Dr Parag
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 24, 2013 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Parikh, Dr Parag
- FDA Inspection 852459 - 2013-10-24
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