FDA Inspection
ADB INTERESTS, LLCADB INTERESTS, LLC – FDA Inspection, Aug 4, 2017
Record Details
This FDA Inspection record concerns ADB INTERESTS, LLC, with an inspection on August 4, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e28e2088-482c-4a4d-9373-7fcaf73e7885
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1021855
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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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 |
| October 26, 2017 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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