FDA Inspection 1245008 — INNOVATIVE TOMOGRAPHY PRODUCTS GMBH

INNOVATIVE TOMOGRAPHY PRODUCTS GMBH — FEI 3014408997

The FDA completed an inspection of INNOVATIVE TOMOGRAPHY PRODUCTS GMBH on Jul 18, 2024 in Bochum. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Jul 18, 2024
Fiscal Year
2024
Product Type
Devices
Project Area
Compliance: Devices
Location
Bochum (Germany)

Citations

IDCFRDescription
265021 CFR 820.30(f)Design verification - Lack of or inadequate procedures
316021 CFR 820.184Lack of or inadequate DHR procedures