FDA finds mess of sterility problems at Emergent

Regulatory NewsRegulatory News | 21 April 2021 |  By 

Officials from the US Food and Drug Administration (FDA) urged Emergent BioSolutions to stop producing vaccines until it corrects a litany of unsafe practices at the plant which compromised the quality of products. These problems were identified following a recent inspection of the plant’s facility in Baltimore.
The company was contracted by Johnson & Johnson to manufacture its COVID-19 vaccine but had to throw out 15 million doses recently due to a mix-up of ingredients.
At the agency’s request, Emergent BioSolutions has agreed to pause new productions while it works with the FDA to resolve potential quality issues.
Acting FDA Commissioner Janet Woodcock and Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, announced on 21 April that the agency “cited a number of observations concerning whether the facility’s processes met our requirements and standards.”
Investigators found an overall failure to prevent cross contamination and failure to keep the facility clean and listed nine violations on the inspection closeout report, also known as FDA Form 483.
For example, investigators found peeling paint on the warehouse floor and a warehouse that was overcrowded with materials staged for entry into manufacturing and quality control sampling.
Security camera footage also showed employees failed to follow procedures for handling non-disinfected medical waste by carrying unsealed bags of medical waste which then came into contact with containers of staged manufacturing materials.
Shower logs and security camera footage also showed employees entering manufacturing areas without following proper showering and gowning procedures.
For the vaccines already manufactured, the product will undergo additional testing to ensure their quality before they are distributed. “We will not allow the release of any product until we feel confident that it meets our expectations for quality,” said Marks and Woodcock in their joint statement.
FDA said these actions are unrelated to an ongoing evaluation of blood clots reported in a very small number of individuals receiving the Johnson & Johnson COVID-19 vaccine.
FDA statement  
Form 483


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