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Adheres to requirements, including 21 CFR Part 820 and Good Manufacturing Practices.
January 6, 2025
By: Kristin Brooks
Cryoport, Inc., a global supply chain solutions provider for the life sciences industry, announced that MVE Biological Solutions, a Cryoport company and global manufacturer of high-quality cryogenic freezers and dewars, has registered all three of its manufacturing facilities (located in Ball Ground, Georgia; New Prague, Minnesota; and Chengdu, China) with the U.S. 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. 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.”
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