FDA Inspection 864708 — CNMC Company, Inc.

CNMC Company, Inc. — FEI 3006073271

The FDA completed an inspection of CNMC Company, Inc. on February 4, 2014 in Nashville, TN. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
February 4, 2014
Fiscal Year
2014
Product Type
Devices
Project Area
Compliance: Devices
Location
Nashville, TN (United States)

Citations

IDCFRDescription
310421 CFR 820.30(j)Design history file
312721 CFR 820.80(e)Documentation
323321 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
331321 CFR 820.120(d)Records, DHR {see also 820.184(e)}
333121 CFR 820.181DMR - not or inadequately maintained