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1098899

Aerolase Corp. — FEI 3004374705

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
August 8, 2019
Fiscal Year
2019
Product Type
Devices
Project Area
Radiation Control and Health Safety Act
Location
Tarrytown, NY (United States)

Facility

Other inspections at this facility

  • 1142261 (VAI Thu May 20 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1010153 (VAI Wed May 03 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 729197 (VAI Fri Jul 15 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
1471221 CFR 820.184DHR - not or inadequately maintained
515021 CFR 1040.10(f)(3)Remote interlock connector
519721 CFR 1040.10(h)(1)(i)User information, adequate instructions
63021 CFR 803.17Lack of Written MDR Procedures