FDA Inspection
Automated Ophthalmics, Inc.Automated Ophthalmics, Inc. – FDA Inspection, Mar 5, 2013
Record Details
This FDA Inspection record concerns Automated Ophthalmics, Inc., with an inspection on March 5, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Automated Ophthalmics, Inc.
- Inspection Date
- March 5, 2013
- Product Type
- Devices
View Company Profile
ID · f96e9f4a-87b9-4660-afd6-bc3b34ce633b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 820861
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
12- 21 CFR 820.80(e)Documentation
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.30(j)Design history file
Showing 10 of 12 citations.
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Other FDA inspections of Automated Ophthalmics, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| February 13, 2026 | VAI | Baltimore District Office | Compliance: Medical Devices |
| 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 |
| December 3, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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