FDA Inspection 802346 — Surgical Appliance Industries Inc

Surgical Appliance Industries Inc — FEI 1511629

The FDA completed an inspection of Surgical Appliance Industries Inc on September 18, 2012 in Cincinnati, OH. 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
September 18, 2012
Fiscal Year
2012
Product Type
Devices
Project Area
Compliance: Devices
Location
Cincinnati, OH (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
313021 CFR 820.100(a)Lack of or inadequate procedures