French pharmaceutical giant Sanofi has received a warning letter from the U.S. Food and Drug Administration following an inspection at its drug manufacturing facility in Framingham. French ...
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. According to the ...
FDA slaps China-based API makers with separate warning letters outlining quality, testing shortfalls
A pair of Chinese manufacturers with active pharmaceutical ingredients that were previously shipped to the U.S. | The FDA ...
Outset Medical (OM) said that all of the issues cited in a warning letter from the FDA in July 2023 have been addressed. Read more here.
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