The FDA made public this week a warning letter that it sent to a Claris Injectables pharmaceutical manufacturing site earlier this month.
Baxter (NYSE:BAX) acquired the Ahmedabad, India-based facility in its $625 million purchase of Claris Lifesciences‘ (BOM:533288) injectable drug business. The FDA noted that the site has twice invalidated out-of-specification results without thoroughly investigating the matter.
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