FDA Inspection 1090847 — M&K Engineering, Inc.

M&K Engineering, Inc. — FEI 3011765094

The FDA completed an inspection of M&K Engineering, Inc. on May 24, 2019 in Woburn, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 24, 2019
Fiscal Year
2019
Product Type
Devices
Project Area
Compliance: Devices
Location
Woburn, MA (United States)

Citations

IDCFRDescription
322621 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule