FDA Inspection 1269632 — Sol-Millennium Medical Inc.
The FDA completed an inspection of Sol-Millennium Medical Inc. on May 8, 2025 in Chicago, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 8, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Chicago, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 733 | 21 CFR 803.50(b)(1) | Reporting Information Reasonably Known |
| 763 | 21 CFR 803.52(c)(10) | Device Available for Evaluation |
| 812 | 21 CFR 803.56 | Submission of Supplement to Individual Report Within One Month |