FDA Inspection
Automated Ophthalmics, Inc.Automated Ophthalmics, Inc. – FDA Inspection, Dec 3, 2009
Record Details
This FDA Inspection record concerns Automated Ophthalmics, Inc., with an inspection on December 3, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Automated Ophthalmics, Inc.
- Inspection Date
- December 3, 2009
- Product Type
- Devices
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ID · 5ffbc0d5-1164-44e4-b71f-0db30afafd5f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 631632
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.30(f)Design verification - documentation
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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 |
| March 5, 2013 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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