FDA Inspection
BARRON ASSOCIATES, INCBARRON ASSOCIATES, INC – FDA Inspection, Dec 19, 2018
Record Details
This FDA Inspection record concerns BARRON ASSOCIATES, INC, with an inspection on December 19, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d0543cdc-b879-4d70-9f58-b6cf8c3c92f5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1076775
- 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 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of BARRON ASSOCIATES, INC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 11, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 3, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for BARRON ASSOCIATES, INC
- FDA Inspection 1250046 - 2024-09-11
- FDA Inspection 1178442 - 2022-08-03
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