# FDA 483 - Automated Ophthalmics, Inc. - February 13, 2026

Source: https://www.keypedia.com/records/483/automated-ophthalmics-inc/e96993bf-dd8f-40a7-ba05-c4ad91816d1f

> FDA 483 for Automated Ophthalmics, Inc. on February 13, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Automated Ophthalmics, Inc.
- Inspection Date: 2026-02-13
- Product Type: device
- Office Name: Baltimore District Office
- Summary: Automated Ophthalmics, Inc. was inspected and cited for multiple deficiencies related to medical device manufacturing. Key issues include the absence of Unique Device Identifiers (UDI) on product labels, inadequate temperature monitoring for product protection, and significant failures in complaint handling and nonconforming product evaluation. These observations indicate a lack of robust quality system controls.

## Related Documents

- [WARNING_LETTER - 2013-03-19](https://www.keypedia.com/records/warning_letter/automated-ophthalmics-inc/b554e7c4-a117-4eac-ae9f-a2bbec4ae7d7)

## Related Officers

- [Andrea D. Gomez](https://www.keypedia.com/people/andrea-d-gomez/778adaf5-c531-419f-b262-4569991fcae8)
- [Christina D. Mello](https://www.keypedia.com/people/christina-d-mello/b523622e-d2dd-4ff6-9b2b-74b3134841de)

Company: https://www.keypedia.com/companies/automated-ophthalmics-inc/3c8cfd75-5794-4841-acac-7e0b25ffe992

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa