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1303056

Automated Ophthalmics, Inc. — FEI 3005906810

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 13, 2026
Fiscal Year
2026
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Elkridge, MD (United States)

Facility

Other inspections at this facility

  • 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))
  • 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
2279621 CFR 801.40(a)Form of a unique device identifier
23190ISO 13485:2016 Clause 7.5.11Product not protected during processing, storage, handling, or distribution
23219ISO 13485:2016 Clause 8.2.2Complaint handling records not maintained
23238ISO 13485:2016 Clause 8.3.1Nonconforming product not adequately evaluated
2326521 CFR 820.35(a)Records of complaint investigations do not include required information