FDA Inspection
Sol-Millennium Medical, Inc.Sol-Millennium Medical, Inc. – FDA Inspection, Dec 20, 2023
Record Details
This FDA Inspection record concerns Sol-Millennium Medical, Inc., with an inspection on December 20, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 7ea8663b-bee9-48b2-b187-1763b242b63a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1225599
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.198(e)Records of complaint investigation - UDI
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.198(e)Records of complaint investigation - UDI
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
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Other FDA inspections of Sol-Millennium Medical, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 8, 2025 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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