Sol-Millennium Medical, Inc. — FDA Facility Profile
Sol-Millennium Medical, Inc. is an FDA-registered facility (FEI 3014312726) located in Chicago, IL, US. RegDataLab tracks 2 FDA inspections and 1 compliance action at this facility.
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What FDA found at this site
- Latest inspection
- May 8, 2025: Voluntary Action Indicated (VAI)
- Inspections on record
- 2 (2 VAI)
- Last OAI inspection
- None on record
- Warning letters
- 1 listed by FDA for this FEI, latest Mar 18, 2024
- Recalls as the recalling firm
- 1, latest May 9, 2024
- Import refusals
- 7
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| May 8, 2025 | Voluntary Action Indicated (VAI) | Lack of or inadequate procedures (21 CFR 820.100(a)) Reporting Information Reasonably Known (21 CFR 803.50(b)(1)) Device Available for Evaluation (21 CFR 803.52(c)(10)) Submission of Supplement to Individual Report Within One Month (21 CFR 803.56) |
| Dec 20, 2023 | Voluntary Action Indicated (VAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Records of complaint investigation - UDI (21 CFR 820.198(e)) Design changes - Lack of or Inadequate Procedures (21 CFR 820.30(i)) Lack of System for Event Evaluations (21 CFR 803.17(a)(1)) |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| May 9, 2024 | Not yet classified | Z-3074-2024 | Syringes with Fixed Needles labeled as:
a) SOL-M:
1) SOL-M 1ml TB Syringe w/Fixed… and 5 more products Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or… |
Facility details
- Company
- Sol-Millennium Medical Inc.
- Location
- Chicago, IL (US)
- Source
- device