FDA Warns Sanofi of Manufacturing Irregularities at Key Facility
1 day ago · On Jan. 15, 2025, a warning letter was sent to Sanofi stating that FDA inspectors found irregularities with the facility’s bioreactor, the vessel used to grow organisms and cells. …
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Our award-winning site in Framingham, MA is among the world’s first digitally enabled facilities to use continuous-biologics-production technology. Its end-to-end platform uses millions of points …
FDA cites contamination concerns in warning to Sanofi MA plant
Jan 22, 2025 · In 2013, Sanofi invested $80 million to build a downstream facility at Framingham dedicated to Fabrazyme. Since then, Sanofi describes Framingham as "among the world’s first …
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Sanofi warned by FDA over 'significant' problems at a key ... - STAT
Jan 21, 2025 · The FDA, whose inspectors visited the Framingham, Mass., plant in June and July 2024, also scolded Sanofi for “multiple” instances in which the facility deviated from so-called …
FDA Warns Sanofi of Manufacturing Irregularities at Key Facility
THURSDAY, Jan. 23, 2025 -- The U.S. Food and Drug Administration has warned the pharmaceutical company Sanofi about significant deviations from Current Good Manufacturing …
FDA warns Sanofi over manufacturing violations - Becker's …
Jan 22, 2025 · The FDA issued a warning letter to Sanofi regarding significant manufacturing violations at its Genzyme Corporation Facility in Framingham, Mass. The letter, dated Dec. 16, …
FDA warns Sanofi of manufacturing irregularities at key facility
6 days ago · Get Instant Summarized Text (Gist) The FDA has identified significant deviations from Current Good Manufacturing Practice at Sanofi's Genzyme plant in Framingham, …
Sanofi opens its first digitally-enabled, continuous manufacturing ...
Oct 15, 2019 · The Framingham digital bio-manufacturing facility is part of Sanofi's integrated, cross-functional biologics hub in Framingham, Massachusetts. A critical global hub for more …
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Dubbed Sanofi at Cambridge Crossing, our new state-of-the-art facility will create an innovation hub promoting close collaboration and integration among business units. Join us and become …