FDA Inspection 722813 — Myotronics-Noromed Inc

Myotronics-Noromed Inc — FEI 3014732

The FDA completed an inspection of Myotronics-Noromed Inc on May 12, 2011 in Kent, WA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI)
End Date
May 12, 2011
Fiscal Year
2011
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Kent, WA (United States)

Citations

IDCFRDescription
333121 CFR 820.181DMR - not or inadequately maintained
45421 CFR 820.40(a)Document review, approval by designated individual

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