FDA Inspection
Aggredyne, Inc.Aggredyne, Inc. – FDA Inspection, Apr 14, 2022
Record Details
This FDA Inspection record concerns Aggredyne, Inc., with an inspection on April 14, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Aggredyne, Inc.
- Inspection Date
- April 14, 2022
- Product Type
- Devices
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ID · d2b4abce-905a-41ec-83ca-5f22be2e55f6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1167084
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.30(g)Design validation - software validation not performed
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Other FDA inspections of Aggredyne, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 5, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 5, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Aggredyne, Inc.
- FDA Inspection 1054387 - 2018-06-05
- FDA Inspection 967771 - 2016-04-05
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