Source: FDA, document on file. FDA released the Form 483 itself. The document linked above is our copy of FDA's file, stored by us so the link cannot break, and FDA's own copy is linked beside it. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3005906810.
Observations5
Issue DateFebruary 13, 2026
StatusNo Warning Letter
Establishment TypeManufacturer
Related Inspections6
Establishment Details
Firm
Automated Ophthalmics, Inc.
Location
Elkridge, Maryland
FEI Number
3005906810
Establishment Type
Manufacturer
Product Type
Devices
Issue Date
February 13, 2026
Country
United States
Inspection History, 2009 to 2026
NAI1
VAI4
OAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.