FDA 483 - McKesson Corporation - July 03, 2018

During an inspection conducted from June 25-29, 2018, and July 2-3, 2018, the U.S. Food and Drug Administration (FDA) issued a Form 483 to McKesson Corporation, a wholesale distributor located in San Francisco, CA. The observations highlighted significant deficiencies in the company's systems for managing suspect and illegitimate products, primarily under the regulatory framework of the Food Drug and Cosmetic Act Section 582(c). Specifically, the FDA noted that McKesson's procedures were inadequate for identifying and quarantining illegitimate products after receiving notifications from trading partners. The company did not consistently perform "shelf-checks" to locate such products in inventory or provide documentation of quarantining them during investigations. Furthermore, McKesson failed to make proper determinations regarding these products, quarantine them, assist trading partners with disposition, or retain necessary samples as required by Section 582(c)(4)(B). A critical issue identified was the deficiency in systems and procedures for notifying all immediate trading partners about confirmed illegitimate products. The company's policy did not mandate notifications within 24 hours to all potentially affected partners. Additionally, transaction data lacked lot/batch numbers, hindering McKesson's ability to trace and promptly inform trading partners who might have received illegitimate products. To address these issues, McKesson must implement robust systems for product identification, quarantine, and enhance its notification and traceability protocols to ensure compliance with federal drug supply chain security regulations.