483
Medsource PharmaceuticalsFDA 483 - Medsource Pharmaceuticals - December 05, 2019
Record Details
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.
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ID · 933f4e30-af21-40fd-8d8b-26865bf49fbb