FDA Inspection
ADB INTERESTS, LLCADB INTERESTS, LLC – FDA Inspection, Oct 26, 2017
Record Details
This FDA Inspection record concerns ADB INTERESTS, LLC, with an inspection on October 26, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · be0134b4-d24c-414c-b2d9-aeb28cc16d47
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1030204
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
Full citation text and observation details available on the Dashboard.
Other FDA inspections of ADB INTERESTS, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 19, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 4, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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