This specific facility ruined the production of 15 million doses of the Johnson & Johnson vaccine. The FDA published this report on Wednesday, stating that the facility had peeling paint and "brown residue" on the walls.
In a report on the factory for Emergent BioSolutions published by the FDA on Wednesday, officials said the facility had peeling paint and "brown residue" on the walls. The report also stated that these conditions could "lead to quality issues during the manufacturing of a product."
"The FDA's inspections are thorough, and these assessments review the quality of manufacturing procedures, including records, staff training, facility operations, drug production and testing and the systems in place to ensure product quality," the FDA said. "During an inspection of Emergent BioSolutions that ended Tuesday, the FDA cited a number of observations concerning whether the facility's processes met our requirements and standards."
Johnson & Johnson stated that all of these concerns will be "addressed promptly and comprehensively."
They added: "The Company will also redouble its efforts as it continues to work toward securing Emergency Use Authorization in the United States for drug substance manufactured at Emergent Bayview as quickly as possible, so that the Company can help bring an end to this global pandemic."
The facility has now halted all vaccine production. Last month, 15 million vaccines were ruined when an employee mixed up ingredients. None of the COVID-19 vaccines produced from this plant have been distributed in the US.
"For the vaccines already manufactured, the products will undergo additional testing and will be thoroughly evaluated to ensure their quality before any potential distribution. We will not allow the release of any product until we feel confident that it meets our expectations for quality," the FDA said.
"The FDA's feedback will help continue to improve and strengthen the supply chain for Johnson & Johnson's vaccine," the facility's parent company Emergent BioSolutions said. "While we are never satisfied to see shortcomings in our manufacturing facilities or process, they are correctable and we will take swift action to remedy them."