FDA 483 - AstraZeneca Nijmegen B.V. - September 19, 2019

An FDA inspection conducted at MedImmune Pharma BV, a drug product manufacturer located in Nijmegen, The Netherlands, from September 12-19, 2019, identified significant observations documented in a Form FDA 483. The inspection highlighted two primary areas of concern related to regulatory manufacturing practices.

Firstly, investigators found inadequate deviation investigations. Specifically, in October 2018, four HEPA filters in Grade A and B aseptic areas failed integrity tests. Two associated deviations were initiated but ultimately classified as minor without adequately assessing the potential impact on drug products manufactured during the affected period, indicating a lack of thoroughness in evaluating potential product contamination risks.

Secondly, the facility's procedures designed to prevent microbiological contamination of sterile drug products were not consistently followed. Inspectors observed operators making abrupt and excessive movements during aseptic filling room setup, which can compromise sterility. Furthermore, an operator failed to disinfect gloves after touching multiple non-sterile surfaces within the aseptic environment, posing a direct risk of contamination.

These observations require a formal response from MedImmune Pharma BV outlining corrective actions to address the identified deficiencies and ensure compliance with regulatory standards for sterile drug manufacturing.