FDA 483 - AstraZeneca Pharmaceuticals LP - June 07, 2024

AstraZeneca Pharmaceuticals LP Frederick Manufacturing Center received a Form 483 citing four observations related to significant manufacturing and quality control deficiencies. Issues include unmitigated contamination risks in drug substance upstream manufacturing, deficient procedures for cleaning and facility maintenance, inadequate documentation of product quality impact from quality events, and a lack of audit trail review for analytical instruments. This inspection highlights repeat observations regarding system deficiencies.