FDA Inspection
Portal 724 LLCFDA Inspection 1271790 - Portal 724 LLC - June 05, 2025
Record Details
This FDA Inspection record concerns Portal 724 LLC, with an inspection on June 5, 2025, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 640319f2-99c5-4570-b207-eb766b378070
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1271790
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Portal 724 LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 21, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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