FDA hits Mi­a­mi Uni­ver­si­ty in Ohio with a warn­ing let­ter over fal­si­fied da­ta

The FDA ham­mered a con­tract test­ing lab at Mi­a­mi Uni­ver­si­ty in Ohio with a warn­ing let­ter af­ter un­cov­er­ing im­prop­er da­ta han­dling and fal­si­fi­ca­tion.

Fol­low­ing an in­spec­tion last No­vem­ber, the FDA said the lab, which per­forms CGMP test­ing of crude he­parin and he­parin API, said a pri­or au­dit caught a stu­dent an­a­lyst fal­si­fy­ing da­ta.

The let­ter al­leges that im­me­di­ate­ly be­fore the FDA’s in­spec­tion, the lab, and the rep­re­sen­ta­tives from Mi­a­mi Uni­ver­si­ty’s he­parin sodi­um cus­tomer, per­formed an au­dit and af­ter re­view­ing the raw test da­ta, the risk as­sess­ment de­ter­mined that a stu­dent an­a­lyst had fal­si­fied da­ta.

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