FDA Inspection
Automated Ophthalmics, Inc.Automated Ophthalmics, Inc. – FDA Inspection, Feb 13, 2026
Record Details
This FDA Inspection record concerns Automated Ophthalmics, Inc., with an inspection on February 13, 2026, issued by the Baltimore District Office, covering medical devices & rad health.
- Company
- Automated Ophthalmics, Inc.
- Inspection Date
- February 13, 2026
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · cf1f49e6-b73e-4dcd-875a-6d1f7ffd5b3c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1303056
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
5- 21 CFR 801.40(a)Form of a unique device identifier
- ISO 13485:2016 Clause 8.2.2Complaint handling records not maintained
- ISO 13485:2016 Clause 8.3.1Nonconforming product not adequately evaluated
- 21 CFR 820.35(a)Records of complaint investigations do not include required information
- ISO 13485:2016 Clause 7.5.11Product not protected during processing, storage, handling, or distribution
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Other FDA inspections of Automated Ophthalmics, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 29, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 8, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 11, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 5, 2013 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 3, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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