FDA Inspection 1303056 — Automated Ophthalmics, Inc.
The FDA completed an inspection of Automated Ophthalmics, Inc. on February 13, 2026 in Elkridge, MD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 13, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Elkridge, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22796 | 21 CFR 801.40(a) | Form of a unique device identifier |
| 23190 | ISO 13485:2016 Clause 7.5.11 | Product not protected during processing, storage, handling, or distribution |
| 23219 | ISO 13485:2016 Clause 8.2.2 | Complaint handling records not maintained |
| 23238 | ISO 13485:2016 Clause 8.3.1 | Nonconforming product not adequately evaluated |
| 23265 | 21 CFR 820.35(a) | Records of complaint investigations do not include required information |