FDA Inspection
Douglas TerpDouglas Terp – FDA Inspection, Jun 28, 2021
Record Details
This FDA Inspection record concerns Douglas Terp, with an inspection on June 28, 2021, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Douglas Terp
- Inspection Date
- June 28, 2021
- Product Type
- Devices
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ID · 1139e483-b1e0-4581-9b93-8faca0d1834d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1146102
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 812.2(c)(3)Needs IDE; diagnostic device exemption conditions not met
- 21 CFR 812.42Sponsor began study before IRB/FDA approval
- 21 CFR 50.20Consent not obtained, exceptions do not apply
- 21 CFR 812.5(a)Label does not contain required information
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