FDA WARNING_LETTER - Sol-Millennium Medical, Inc. - December 20, 2023

The FDA issued a Warning Letter to Sol-Millennium Medical, Inc. following an inspection from December 14-20, 2023. The firm, a Specification Developer, Initial Importer, and Complaint File Establishment for syringes and needles, was cited for significant violations.

**Unapproved Device Violations:** Sol-Millennium marketed several syringe configurations (e.g., luer lock with blunt fill needles, luer slip, eccentric tip, low dead space, and accessories) under K101359, which only cleared standard luer lock syringes without needles. These changes constitute major modifications to intended use and/or design that significantly affect safety/effectiveness, requiring new 510(k) submissions or PMAs. The FDA noted postmarket safety signals, including cracks, breakage, and luer connectivity failures.

**Registration & Listing Violations:** The firm failed to annually register and list for fiscal year 2024. Its registered Suwanee, GA site was no longer the global headquarters for complaint handling, which moved to Chicago, IL in 2020. Design activities occur in Lugano, Switzerland, and Shanghai, China, but these facilities were not registered, nor were devices listed with their manufacturing sites. Additionally, product labels still bear former headquarters' addresses (Lawrenceville, GA and Suwanee, GA), misbranding devices.

**Quality System Regulation Violations (21 CFR Part 8