Company
United StatesAutomated Ophthalmics, Inc., Elkridge, MD – FDA Inspections
Inspection records and compliance data for Automated Ophthalmics, Inc. in Elkridge, Maryland. 6 FDA inspections on record (1 OAI), 1 Form 483, 1 warning letter, last inspected February 13, 2026.
Company Profile
This profile covers Automated Ophthalmics, Inc. based in Elkridge, Maryland, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 1
- VAI
- 3
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 1
First inspected December 3, 2009. Last inspected February 13, 2026.
Most cited issue areas
- Nonconforming product, Lack of or inadequate procedures2 inspections
- Complaint handling records not maintained1 inspection
- Design control - no procedures1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 13, 2026 | VAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1303056 |
| October 29, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1107868 |
| February 8, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 959558 |
| December 11, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 858568 |
| March 5, 2013 | OAI | Medical Devices & Rad Health · Compliance: Devices | 820861 |
| December 3, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 631632 |
FDA documents
Form 483s (1)
Warning Letters (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Automated Ophthalmics, Inc.
FEI Number
3005906810
Address
6671 Santa Barbara Rd Ste F, Elkridge, Maryland 21075, United States
Country
United States
ID: 3c8cfd75-5794-4841-acac-7e0b25ffe992