FDA Inspection
Pattanam D. Srinivasan, MDPattanam D. Srinivasan, MD – FDA Inspection, Sep 27, 2013
Record Details
This FDA Inspection record concerns Pattanam D. Srinivasan, MD, with an inspection on September 27, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Pattanam D. Srinivasan, MD
- Inspection Date
- September 27, 2013
- Product Type
- Devices
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ID · 4d2125af-0e43-4414-a120-c1f08323dab8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 850635
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
28- 21 CFR 50.27(a)Copy of consent form not provided
- 21 CFR 812.150(a)(6)Investigator final report
- 21 CFR 812.7(a)Promotion or test marketing
- 21 CFR 812.2(c)(3)Needs IDE; diagnostic device exemption conditions not met
- 21 CFR 812.100Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.43(c)(4)(i)No investigation agreement statement of commitment
- 21 CFR 812.36(d)No FDA approval for treatment IDE
- 21 CFR 812.36(e)No IRB approval for treatment use
- 21 CFR 50.25(a)(6)Compensation, medical treatment in event of injury
- 21 CFR 50.27(a)Consent form not approved/signed/dated
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