1015188

Medical Techniques, Inc. — FEI 1000306296

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 21, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Compliance: Devices
Location
North Salt Lake, UT (United States)

Citations

IDCFRDescription
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
310421 CFR 820.30(j)Design history file
322621 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
323521 CFR 820.72(a)Equipment control activity documentation
328521 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
342621 CFR 820.50(a)(1)Documented evaluation
369621 CFR 820.100(b)Documentation
54121 CFR 820.70(c)Environmental control Lack of or inadequate procedures