FDA Inspection 950359 — Human Design Medical, LLC

Human Design Medical, LLC — FEI 3010817335

The FDA completed an inspection of Human Design Medical, LLC on October 2, 2015 in Charlottesville, VA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 2, 2015
Fiscal Year
2016
Product Type
Devices
Project Area
Compliance: Devices
Location
Charlottesville, VA (United States)

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures