FDA Inspection
Avedro, Inc.Avedro, Inc. – FDA Inspection, May 25, 2012
Record Details
This FDA Inspection record concerns Avedro, Inc., with an inspection on May 25, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Avedro, Inc.
- Inspection Date
- May 25, 2012
- Product Type
- Devices
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ID · bae73ad0-3e02-47a5-bca8-c31df5d1cc04
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 783218
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.30(g)Design validation - production units
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Other FDA inspections of Avedro, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 26, 2025 | Not classified | New England District Office | Compliance: Medical Devices |
| February 10, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 12, 2014 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Avedro, Inc.
- FDA Inspection 1275997 - 2025-06-26
- FDA Inspection 959091 - 2016-02-10
- FDA Inspection 867602 - 2014-02-12
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