Repeat Offender: Baxter BioScience Corporation, the FDA and Too Much Mold to Count

Published: Jun 17, 2013

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As the FDA continues its push to crack down on manufacturing violations, warning letters have become standard fare. But every so often, a missive stands out from the crowd thanks to the sort of violations that the agency encounters. The latest example is Baxter Healthcare, which has become a repeat offender with serious problems at a few different plants. For instance, a Baxter plant in North Carolina had various environmental issues. Specifically, there was a failure to sanitize and sterilize some equipment and the agency found that various filters and screen used in a product fill line had contained “varying amounts of discolored areas, chipping paint, multi-colored coalescing droplets and clumps of dark material that FDA testing later revealed was mold.” Although Baxter halted shipments of products made on that line after the November 2012 agency inspection, the FDA noted the drugmaker did not determine how long the problems existed and failed to identify how the mold was allowed to “proliferate to a level of TNTC (Too Numerous Too Count) in several environmental samples directly over your fill line.”

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