Automated Ophthalmics, Inc.
Form 483 issued February 13, 2026 · Elkridge, Maryland
- Inspection
- Feb 10 – Feb 13, 2026
- Observations
- 5
- Pages
- 5
- FEI number
- 3005906810
In short: On February 13, 2026, FDA issued a Form 483 with 5 observations to Automated Ophthalmics, Inc. in Elkridge, Maryland (FEI 3005906810) after an inspection that ran Feb 10 – Feb 13, 2026. Most observations concern production & process controls.
At a glance
Observations span 1 system, led by production & process controls.
What FDA observed
Preview: the opening words of each observation- 01
The medical device(s) label did not have a unique device…
- 02ISO 13485:2016 Clause 7.5.11
Product was not protected from alteration, contamination, or damage during processing, storage…
- 03ISO 13485:2016 Clause 8.2.2
Complaint handling records were…
- 04ISO 13485:2016 Clause 8.3.1
Nonconforming product was not adequately evaluated to determine the need for an investigation and notification of…
This inspection in context
Questions about this 483
What did FDA find at Automated Ophthalmics, Inc.?
FDA listed 5 observations on this Form 483, mostly about production & process controls. The opening words of each observation are shown on this page.
When was Automated Ophthalmics, Inc. inspected by FDA?
The inspection ran Feb 10 – Feb 13, 2026, and the Form 483 is dated February 13, 2026.
How do I get the full Form 483 for Automated Ophthalmics, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.