Sol-Millennium Follow-up Response to FDA Communication
07 Dec 2023
CHICAGO--(BUSINESS WIRE)--The FDA issued a Safety Communication on November 30, 2023, stating concerns that certain plastic syringes made in China may not provide consistent and adequate quality or performance. The notice lists concerns over “leaks, breakage, and other problems after manufacturers made changes to the syringe dimensions.” Sol-Millennium has not incorporated any changes to the dimensions of its syringes. Sol-Millennium users can continue to trust that Sol-Millennium’s syringes will function as intended, as the FDA safety notice does not apply to any Sol-Millennium products.
Sol-Millennium manufacturing locations in China adhere to stringent sampling techniques for raw material, in-process inspections, and final inspections prior to product release. “We have been supplying the US market for over a decade and continue to from these manufacturing locations which are ISO 13485 certified, ensuring that all material, manufacturing, and testing standards are adhered to for every product we offer,” said Manu Kalia, Director of Quality Assurance and Regulatory Affairs.
Sol-Millennium had already increased manufacturing capacity and stock levels in U.S. warehouse to be able service customers consistently throughout this time. Please reach out to local Sol-Millennium representative or contact Sol-Millennium customer service at info@sol-m.com or 833-637-0857 with any questions.
Sol-Millennium Medical Group is one of the world's largest manufacturers of needles and syringes. It is vertically integrated with locations across the globe. Sol-Millennium's innovative technology helps positive patient outcomes, saves on medication, and enhances both clinician and patient experience. With an international sales team dedicated to delivering knowledge and outstanding customer service, Sol-Millennium’s goal is to partner with those in healthcare, focusing on a healthier tomorrow.
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