1. Pink Sheet

The Baxter/Claris Warning Letter: Out Of Spec, Out Of Mind

 
• By Bowman Cox

US FDA's inspection found a major problem in the operations of the facility that became Baxter’s when it acquired Claris: staff were blaming the laboratory for out-of-specification test results when they should have been fixing the manufacturing process. The result: a warning letter packed with assignments for the new owners.

Warning Rubber Stamp

US FDA highlighted spurious invalidation of out-of-specification results in a warning letter stemming from an inspection of a Claris Injectables Ltd. plant that began on the day in July 2017 that Baxter International Inc. acquired Claris Lifesciences Ltd.'s injectables unit.

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