FDA Inspection
INNOVATIVE TOMOGRAPHY PRODUCTS GMBHINNOVATIVE TOMOGRAPHY PRODUCTS GMBH – FDA Inspection, Jul 18, 2024
Record Details
This FDA Inspection record concerns INNOVATIVE TOMOGRAPHY PRODUCTS GMBH, with an inspection on July 18, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d09665ac-f89a-4542-9e1c-8c241e5997ec
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1245008
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
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