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1107868

Automated Ophthalmics, Inc. — FEI 3005906810

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 29, 2019
Fiscal Year
2020
Product Type
Devices
Project Area
Compliance: 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))
  • 959558 (NAI Mon Feb 08 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 858568 (NAI Wed Dec 11 2013 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
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
54121 CFR 820.70(c)Environmental control Lack of or inadequate procedures