FDA Inspection 809406 — Wexford Labs Inc

Wexford Labs Inc — FEI 1000147951

The FDA completed an inspection of Wexford Labs Inc on December 6, 2012 in Kirkwood, MO. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 2 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
December 6, 2012
Fiscal Year
2013
Product Type
Devices
Project Area
Compliance: Devices
Location
Kirkwood, MO (United States)

Citations

IDCFRDescription
312021 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
315921 CFR 820.184DHR content