Cryoport, Inc. (NASDAQ: CYRX), a global leader in supply chain solutions for the life sciences industry, today announced that MVE Biological Solutions ("MVE"), a Cryoport company and the leading global manufacturer of high-quality cryogenic freezers and dewars, has officially registered all three of its manufacturing facilities (located in Ball Ground, Georgia; New Prague, Minnesota; and Chengdu, China) with the U.S. Food and Drug Administration ("FDA"). Additionally, all applicable MVE-manufactured cryogenic freezers and dewars are now listed with the FDA.
To meet the standards of FDA-registered facilities, MVE adheres to stringent requirements, including but not limited to 21 CFR Part 820 and Good Manufacturing Practices ("GMP"). This FDA registration and product listing is in addition to MVE's existing ISO 13485 certification.
"MVE's achievement underscores our commitment to delivering the highest-quality and most reliable supply chain solutions for the life sciences industry," said Jerrell Shelton, CEO, Cryoport. "Our MVE team's dedication to serving our clients' needs and bringing lifesaving therapies to patients is consistent with the high standards we practice in all business units companywide. This FDA registration reflects MVE's commitment to excellence by meeting the strictest of global regulatory standards."