Millstone Medical Outsourcing LLC registered with the Food & Drug Administration as a human tissue bank for its facility in Memphis.
Fall River, Mass.-based Millstone also completed the registration and licensing requirements necessary to store and distribute human tissue and bone products in six states and is pursuing registration or licensing in four more. The Memphis location, in addition to forthcoming tissue storage sites, was selected to to take advantage of later ship times, which will reduce transit times, enhance quality and decrease costs, according to a press release. The states where Millstone has FDA approval are Connecticut, Delaware, Illinois, Louisiana, Oregon and Tennessee; registration is still pending in California, Florida, Maryland and New York.
Registration with the FDA as a human tissue bank entails a wide variety of technical requirements related to environmental controls, equipment, supplies, labeling, tracking, processing, storage and distribution.Millstone just opened a 5,400-square-foot clean room at its Fall River headquarters in February of this year, adding to the 12,000 square feet of clean room space it opened in April 2009.
Millstone claims a roster of 50 orthopedic device-making clients, “including nine of the top 10,” according to the press release. The company offers advanced inspection, sterile and non-sterile packaging, loaner kit processing and distribution services.