FDA Inspection 847861 — NOBEL PROCERA SERVICES INC.

NOBEL PROCERA SERVICES INC. — FEI 3006290317

The FDA completed an inspection of NOBEL PROCERA SERVICES INC. on September 12, 2013 in Quebec. 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
September 12, 2013
Fiscal Year
2013
Product Type
Devices
Project Area
Compliance: Devices
Location
Quebec (Canada)

Citations

IDCFRDescription
317221 CFR 820.198(c)Investigation of device failures
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures