Drugs

Emergent Bio Covid Vaccine 9-Item FDA Form-483

In an unprecedented move, FDA has released an inspection report less than 24 hours after it completed an inspection of Emergent BioSolutions’ Baltimore manufacturing plant that shows troubling findings which led to an agreement to shut down operations until corrections are implemented (see earlier story). The plant is key to Johnson & Johnson’s Covid-19 vaccine because certain components are made there, but without FDA approval the materials cannot currently be used for any upcoming vaccine supply.

Acknowledging the importance of the manufacturing plant, FDA acting commissioner Janet Woodcock says the agency is working with the company to address the quality and manufacturing deficiencies. “For the vaccines already manufactured, [BioSolutions’] products will undergo additional testing and will be thoroughly evaluated to ensure their quality before any potential distribution,” she says. “We will not allow the release of any product until we feel confident that it meets our expectations for quality.”

Additionally, Woodcock explained that the agency’s actions at the plant are unrelated to an ongoing evaluation by FDA and CDC that is analyzing extremely rare cases of blood clots reported in a few individuals after receiving the Johnson & Johnson vaccine.

According to the nine-item FDA Form-483 from the inspection, Emergent failed to investigate adequately a cross contamination of a viral vaccine drug substance from another vaccine client’s materials at the plant. FDA investigators also found that the building used for manufacturing a viral vaccine drug substance is not maintained in a clean and sanitary condition. For example, they said waste generated during production of the vaccine drug substance is not decontaminated using a redacted process that was qualified for use.

Additionally, FDA cited Emergent over components and product containers not being handled or stored in a manner to prevent contamination. And the agency took issue with certain written procedures, employee training, and its equipment in the microbiology lab not being large enough for ongoing operations. And regarding cleanliness, the agency said the manufacturing rooms and corridors are not adequately cleaned, and painted walls and floors are peeling.

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