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Pharmaceuticals / Inspections and Audits

McKesson Draws FDA’s First DSCSA-Related Warning Letter

Feb. 22, 2019

The FDA issued its first warning letter under the Drug Supply Chain Security Act (DSCSA), hitting McKesson for violating verification requirements and allegedly shipping illegitimate product.

In the warning letter dated Feb. 7, the agency claimed the pharma giant shipped illegitimate product to trading partners throughout 2016, including three separate Rite Aid pharmacies.

The firm’s investigation of the incidents determined that the packages of oxycodone hydrochloride were replaced with another product while under the company’s control.

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