Automated Ophthalmics, Inc.
FDA inspection history in Elkridge, Maryland, 2013 to 2026
- 1
- Form 483
- 1
- Close-out
- 1
- Warning letter
Every document, by year
- Form 483
- Close-out
- Warning letter
2013: one warning letter; 2014: one close-out letter; 2026: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2013–14One warning letter and one close-out letter, at Elkridge, Maryland.
- 2026One Form 483, at Elkridge, Maryland.
Cited most
Across all Automated Ophthalmics observations on file
- ISO 13485:2016 Clause 7.5.111
- ISO 13485:2016 Clause 8.2.21
- ISO 13485:2016 Clause 8.3.11
- 21 CFR 801.40(a)Form of a unique device identifier1
- 21 CFR 820.35(a)Control of records1
The complete Automated Ophthalmics file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Elkridge, Maryland
One Form 483, one close-out letter and one warning letter · 2013 to 2026 · 5 observations
Latest: Form 483, Feb 13, 2026 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-02-13 | 483 Form 483 | Elkridge, Maryland | 5 | $99 |
| 2014-02-18 | Close-out Close-out letter | Elkridge, Maryland | — | $99 |
| 2013-06-05 | Warning letter Warning letter | Elkridge, Maryland | — | $99 |
FEI number 3005906810 · most recent document Feb 13, 2026
About Automated Ophthalmics, Inc.
How many FDA Form 483s has Automated Ophthalmics, Inc. received?
FDA Intel has 1 Form 483 on file for Automated Ophthalmics, Inc.; the most recent is dated Feb 13, 2026.
When was Automated Ophthalmics, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Automated Ophthalmics, Inc. is a Form 483 dated Feb 13, 2026, for the site in Elkridge, Maryland.
What did FDA cite at Automated Ophthalmics, Inc.?
The regulations cited most in the observations on file for Automated Ophthalmics, Inc. are ISO 13485:2016 Clause 7.5.11, 1 time; ISO 13485:2016 Clause 8.2.2, 1 time; ISO 13485:2016 Clause 8.3.1, 1 time.
Has Automated Ophthalmics, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Automated Ophthalmics, Inc.; the most recent is dated Jun 5, 2013.