FDA 483 - AstraZeneca Pharmaceuticals LP - March 19, 2021

An FDA inspection of AstraZeneca Pharmaceuticals LP Frederick Manufacturing Center revealed significant deficiencies across its operations. The firm failed to ensure the quality control unit's responsibilities were fully followed, including issues with electronic system validation and supplier material testing. Additionally, the facility demonstrated inadequate microbial control in drug substance manufacturing and failed to conduct thorough investigations into deviations and out-of-specification results.