FDA Inspection 988179 — Young Dental Manufacturing I, LLC

Young Dental Manufacturing I, LLC — FEI 1941138

The FDA completed an inspection of Young Dental Manufacturing I, LLC on Sep 28, 2016 in Earth City, MO. 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
Sep 28, 2016
Fiscal Year
2016
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Earth City, MO (United States)

Citations

IDCFRDescription
317021 CFR 820.198(b)Review and evaluation for investigation
369621 CFR 820.100(b)Documentation
434221 CFR 211.142(b)Storage under appropriate conditions