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858568

Automated Ophthalmics, Inc. — FEI 3005906810

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
December 11, 2013
Fiscal Year
2014
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Elkridge, MD (United States)

Facility

Other inspections at this facility

  • 1303056 (VAI Fri Feb 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1107868 (VAI Tue Oct 29 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 959558 (NAI Mon Feb 08 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 820861 (OAI Tue Mar 05 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 631632 (VAI Thu Dec 03 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
237121 CFR 820.30(a)Design control - no procedures
312521 CFR 820.80(d)Lack of or inadequate final acceptance procedures
369621 CFR 820.100(b)Documentation