FDA Inspection 802846 — Best Nomos

Best Nomos — FEI 2434141

The FDA completed an inspection of Best Nomos on Oct 5, 2012 in Pittsburgh, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Oct 5, 2012
Fiscal Year
2013
Product Type
Devices
Project Area
Compliance: Devices
Location
Pittsburgh, PA (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
366921 CFR 820.20(c)Management review - defined interval, sufficient frequency
369621 CFR 820.100(b)Documentation