FDA Inspection 976426 — Trigon America LLC

Trigon America LLC — FEI 3003596442

The FDA completed an inspection of Trigon America LLC on May 16, 2016 in Aurora, IL. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI)
End Date
May 16, 2016
Fiscal Year
2016
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Aurora, IL (United States)

Citations

IDCFRDescription
1472021 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
313021 CFR 820.100(a)Lack of or inadequate procedures
316821 CFR 820.198(a)Complaints