FacilityLedger

Device establishmentActive, RegisteredFDA warning letter on file

Sol-Millennium Medical, Inc.

Sol-Millennium Medical, Inc. is an FDA-registered device establishment (FEI 3014312726) located in Chicago, Illinois. The facility is active, registered. Its most recent FDA inspection on record (2025-05-08) was classified VAI. FDA has issued 1 warning letter(s) to this facility.

FDA warning letter

Mar 18, 2024
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
Read the letter on FDA.gov ›

A warning letter is FDA's formal notice of significant violations that require prompt correction. It can hold up product approvals, trigger import alerts, and put supply agreements at risk until the issues are resolved and FDA closes it out.

Recalls (1)

May 9, 2024 Class II
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 modification to the device s intended use.
OngoingView source data ›

Recall data from openFDA enforcement reports (FDA Recall Enterprise System).

Establishment record

FEI Number
3014312726
Address
311 S Wacker Drive, Chicago, Illinois
Establishment type
Device establishment
Products / operations
General Hospital, Complaint File Establishment per 21 CFR 820.198, Develop Specifications But Do Not Manufacture At This Facility, General, Plastic Surgery, Ear, Nose, Throat, Clinical Chemistry, Unknown
Registration status
Active, Registered

Verify this record in FDA source data ›

Inspection history

Inspections on file
May 8, 2025 · Voluntary Action Indicated (VAI)
Dec 20, 2023 · Voluntary Action Indicated (VAI)
Form 483 observations
May 8, 2025, 4 observations: Lack of or inadequate procedures; Reporting Information Reasonably Known; Device Available for Evaluation
Dec 20, 2023, 4 observations: Lack of or inadequate complaint procedures; Lack of System for Event Evaluations; Records of complaint investigation - UDI

FDA record timeline

FDA inspection
VAI classification
Form 483
4 observations
Recall
Class II — 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 modification to the device s intended use.
Source ›
Warning letter
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
Source ›
FDA inspection
VAI classification
Form 483
4 observations

Combined chronology of the public records shown on this page. FDA coverage varies by dataset and year.

Questions

Is Sol-Millennium Medical, Inc. registered with the FDA?

Yes. Sol-Millennium Medical, Inc. is an FDA-registered device establishment (FEI 3014312726) in Chicago, Illinois. Its current registration status is Active, Registered.

Has Sol-Millennium Medical, Inc. received an FDA warning letter?

Yes. FDA issued a warning letter to Sol-Millennium Medical, Inc.; the most recent is dated Mar 18, 2024 (Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device).

What does Sol-Millennium Medical, Inc. do?

Sol-Millennium Medical, Inc.'s FDA-registered operations are: General Hospital, Complaint File Establishment per 21 CFR 820.198, Develop Specifications But Do Not Manufacture At This Facility, General, Plastic Surgery, Ear, Nose, Throat, Clinical Chemistry, Unknown.

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Source: FDA public data · status as of 2026-08-22

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