FDA Inspection
Macbrud CorporationMacbrud Corporation – FDA Inspection, Oct 20, 2026
Record Details
This FDA Inspection record concerns Macbrud Corporation, with an inspection on October 20, 2026, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Macbrud Corporation
- Inspection Date
- October 20, 2026
- Product Type
- Devices
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ID · 906bb31a-a456-4884-a71b-8a693926b0dc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1342172
- Project area
- Compliance: Devices
FDA Citations
2- ISO 13485:2016 Clause 4.1.6Evidence of conformity to the acceptance criteria not maintained
- ISO 13485:2016 Clause 7.1Records of supplier (re)evaluation, selection, and monitoring not maintained
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Other FDA inspections of Macbrud Corporation
4| Date | Classification | Office | Project area |
|---|---|---|---|
| May 21, 2025 | VAI | Florida District Office | Compliance: Medical Devices |
| November 18, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 23, 2020 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 23, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Macbrud Corporation
- FDA Inspection 1271827 - 2025-05-21
- FDA Inspection 1191217 - 2022-11-18
- FDA Inspection 1116281 - 2020-01-23
- FDA Inspection 841232 - 2013-07-23
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