Temperature-controlled supply chain solutions firm Cryoport has registered all three of its MVE Biological Solutions (MVE) manufacturing facilities with the US Food and Drug Administration (FDA).
A Cryoport company that specialises in cryogenic freezers and dewars, MVE has manufacturing locations in Ball Ground in Georgia, New Prague in Minnesota, and Chengdu in China.
In addition to the locations, all applicable MVE-manufactured cryogenic freezers and dewars are now also listed with the FDA.
Jerrell Shelton, CEO of Cryoport, said the news highlights the company’s commitment to delivering high-quality and reliable supply chain solutions for the life sciences industry.
“The FDA registration reflects MVE’s commitment to excellence by meeting the strictest of global regulatory standards.”
Read more: How Cryoport stays ahead in delivering cell and gene therapies
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).
The FDA registration and product listing is in addition to MVE’s existing ISO 13485 certification.
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