FDA Inspection 864382 — Vidco, Inc.

Vidco, Inc. — FEI 3020646

The FDA completed an inspection of Vidco, Inc. on February 3, 2014 in Beaverton, OR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 3, 2014
Fiscal Year
2014
Product Type
Devices
Project Area
Compliance: Devices
Location
Beaverton, OR (United States)

Citations

IDCFRDescription
1471721 CFR 820.30(g)Design validation - software validation documentation
1472221 CFR 820.40Procedures not adequately established or maintained
323321 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ