FDA Inspection 857370 — Advanced Medical Innovations

Advanced Medical Innovations — FEI 1000125255

The FDA completed an inspection of Advanced Medical Innovations on Nov 26, 2013 in Northridge, CA. 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
Nov 26, 2013
Fiscal Year
2014
Product Type
Devices
Project Area
Compliance: Devices
Location
Northridge, CA (United States)

Citations

IDCFRDescription
310421 CFR 820.30(j)Design history file
333121 CFR 820.181DMR - not or inadequately maintained

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.