FDA Inspection 762854 — Nova Biomedical Corporation

Nova Biomedical Corporation — FEI 1219029

The FDA completed an inspection of Nova Biomedical Corporation on January 13, 2012 in Waltham, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 13, 2012
Fiscal Year
2012
Product Type
Devices
Project Area
Compliance: Devices
Location
Waltham, MA (United States)

Citations

IDCFRDescription
368021 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures