FDA 483 - Medsource Pharmaceuticals - December 05, 2019

Medsource Pharmaceuticals, a drug repacker and relabeller in Rancho Santa Margarita, CA, received an FDA Form 483 citing significant deficiencies across its quality system, production controls, and equipment management. Observations included a lack of annual product reviews, a deficient change control program, absence of expiration dating procedures for repackaged drugs, and inadequate cleaning validation and equipment qualification. These issues indicate a broad failure to ensure product quality and compliance with good manufacturing practices.