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FDA establishment 3014312726, Chicago, Illinois, United States. Part of Sol-Millennium Medical's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations, its recalls since 2016, and the shipments FDA refused at the border.
Inspections: 2
Official action indicated: 0
Last inspection ended: May 8, 2025
Warning letters: 0
Recalls since 2016: 1
Import refusals since 2024: 1
Import refusals 2014 to 2023: 6, first Jul 14, 2022
Inspections by Fiscal Year
FY2018 to FY2027 to date; 0 classified OAI
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
21 CFR 803.50(b)(1). Reporting Information Reasonably Known An MDR report submitted to FDA did not include all information that was reasonably known to the manufacturer.
21 CFR 803.56. Submission of Supplement to Individual Report Within One Month An individual supplemental report was not submitted to FDA within one month following receipt of information that was not provided when the initial report was submitted.
21 CFR 803.52(c)(10). Device Available for Evaluation An individual medical device manufacturer report submitted per Form FDA 3500A format did not indicate in Block D whether the device was available for evaluation, whether the device was returned to the manufacturer and the date the device was returned to the manufacturer.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
21 CFR 820.198(a). Lack of or inadequate complaint procedures Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
21 CFR 820.30(i). Design changes - Lack of or Inadequate Procedures Procedures for design change have not been adequately established.
21 CFR 803.17(a)(1). Lack of System for Event Evaluations The written MDR Procedure does not include an internal system which provides for timely and effective identification of events that may be subject to medical device reporting requirements.
21 CFR 820.198(e). Records of complaint investigation - UDI Records of complaint investigations do not include required information, including any unique device identifier (UDI) or universal product code (UPC).
Voluntary Action Indicated (VAI)
Recalls
1 drug, device and biologic recalls since 2016, newest first; 0 Class I
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm.FDA Data Dashboard, warning letters and enforcement reports
Chicago, Illinois, United States. Part of