Recently Emergent BioSolutions found themselves in the news due to quality issues, specifically cross-contamination, related to its vaccine production. The deviation investigation report did not include a thorough review of personnel movements in and around the facility as a potential source of the contamination, as cited in the FDA 483 dated April 12, 2021.
Emergent’s failure to resolve its manufacturing quality-control issues led to a contamination of 15 million Johnson & Johnson doses in March 2021, when the company accidentally mixed in AstraZeneca drug substance. The facility halted production for three months before resuming operations in July 2021.Politico
Cross-contamination is a common problem among manufacturing companies in the pharmaceutical and medical device space. This was one of the major shortfalls that led to the problems that Emergent BioSolutions that we’re reading about in the news today as published by the New York Times, ABC News and Politico. Not only did the firm have a problem with cross-contamination but they allegedly hid these problems from inspectors during the FDA inspection in March, 2021.
Download the Emergent 483 FDA Report
Click here to download a copy of the Emergent Manufacturing Operations’ FDA 483 Report. This report details the observations made during the inspection of the vaccine substance manufacturing company.
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For a free copy of this actual inspection please use promo code emergent-483 to download this and other inspection reports at GMP trends. Also, Issue #1086 and Issue #1084 are related to cross-contamination issues found in previous 483 Reports.