FDA Inspection 1103449 — Durham Exchange Club Industries Inc (DECI)

Durham Exchange Club Industries Inc (DECI) — FEI 3000328994

The FDA completed an inspection of Durham Exchange Club Industries Inc (DECI) on September 30, 2019 in Durham, NC. 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 30, 2019
Fiscal Year
2019
Product Type
Devices
Project Area
Compliance: Devices
Location
Durham, NC (United States)

Citations

IDCFRDescription
312521 CFR 820.80(d)Lack of or inadequate final acceptance procedures
50221 CFR 820.60Identification procedures, Lack of or inadequate procedures