FDA Inspection
Sol-Millennium Medical, Inc.Sol-Millennium Medical, Inc. – FDA Inspection, May 8, 2025
Record Details
This FDA Inspection record concerns Sol-Millennium Medical, Inc., with an inspection on May 8, 2025, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f654aa9d-d2ca-4ec4-b0ae-69522d8eb1ae
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1269632
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 803.52(c)(10)Device Available for Evaluation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.50(b)(1)Reporting Information Reasonably Known
- 21 CFR 803.56Submission of Supplement to Individual Report Within One Month
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Other FDA inspections of Sol-Millennium Medical, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 20, 2023 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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