FDA Inspection 846160 — Certified Safety Manufacturing, Inc.

Certified Safety Manufacturing, Inc. — FEI 1000158435

The FDA completed an inspection of Certified Safety Manufacturing, Inc. on August 29, 2013 in Kansas City, MO. 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
August 29, 2013
Fiscal Year
2013
Product Type
Devices
Project Area
Compliance: Devices
Location
Kansas City, MO (United States)

Citations

IDCFRDescription
1472221 CFR 820.40Procedures not adequately established or maintained
333121 CFR 820.181DMR - not or inadequately maintained
383721 CFR 820.25(b)Training records