FDA Inspection 923803 — Advanced Back Technologies, Inc.

Advanced Back Technologies, Inc. — FEI 3004755153

The FDA completed an inspection of Advanced Back Technologies, Inc. on April 21, 2015 in Syosset, NY. 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
April 21, 2015
Fiscal Year
2015
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Syosset, NY (United States)

Citations

IDCFRDescription
369621 CFR 820.100(b)Documentation
405921 CFR 820.22Quality Audits - defined intervals