FDA Inspection 720492 — Ascension Orthopedics, Inc

Ascension Orthopedics, Inc — FEI 3002788818

The FDA completed an inspection of Ascension Orthopedics, Inc on April 7, 2011 in Austin, TX. 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
April 7, 2011
Fiscal Year
2011
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Austin, TX (United States)

Citations

IDCFRDescription
317021 CFR 820.198(b)Review and evaluation for investigation