Emergent BioSolutions Hit with FDA Form 483

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Post-inspection report reveals nine sanitary and process problems at Bayview, Md., facility.

FDA inspectors identified nine conditions at Emergent BioSolutions’ Maryland vaccine manufacturing facility that could lead to product quality issues including unsanitary conditions, inadequate facility size for proper operations, inadequate written procedures, and substandard employee training.

The observations were listed in a redacted FDA inspection closeout report, or Form 483 (PDF), released on April 21, 2021 following a multi-day inspection of the facility. The facility, slated to manufacture Johnson & Johnson’s (J&J’s) COVID-19 vaccine, has not been authorized by FDA to manufacture or distribute the vaccine.

FDA halted production and distribution of the vaccine drug substance at the Bayview plant on April 16, 2021, two weeks after instructing J&J to take over production of its vaccine drug substance at the facility. Previously, J&J reported that vaccine drug substance materials for 15 million doses of the company’s COVID-19 vaccine were rejected due to a manufacturing problem.

Observations identify human, process, and facility errors

FDA inspectors noted that Emergent did not thoroughly investigate several unexplained discrepancies including cross-contamination of a viral vaccine drug substance batch.


The building used for manufacturing the vaccine drug substance was not maintained in a clean and sanitary condition; peeling paint and brown or black residue was observed on floors and walls. In addition, FDA inspectors noted in the Form 483 that the building used to manufacture the viral vaccine drug substance was “not of suitable size, design, and location to facilitate cleaning, maintenance, and proper operations.” Waste handling procedures were inadequate, and areas of the facility were overcrowded, FDA said.

The facility also was cited for not following written production and process control procedures and a lack of documentation. Infractions included employees compacting, by hand, unsealed bags of medical waste from manufacturing in an area where raw materials were staged, removing protective garments onto the warehouse floor where raw materials were staged, and failing to follow proper gowning procedures when switching from different manufacturing areas.

Product components, containers, and closures were not handled properly, FDA reported. Unsealed bags of manufacturing waste were handled near raw materials.

Written procedures to assure the identity, strength, quality, and purity of the drug substance were inadequate, FDA noted, and employees were not trained in operations they performed. Inadequate equipment, utensils, and laboratory space were also observed.

In a press release announcing the Form 483, FDA noted that the agency is working with the company to identify ways to remedy the issues. “Indeed, it is often in the public’s best interest that the FDA work with firms to quickly resolve compliance matters to ensure that the public has access to medical products that meet the agency’s high standards for quality, safety, and effectiveness,” FDA noted in the statement.

Additional testing will be performed on vaccines already manufactured at the facility before any potential distribution, FDA reported.

Source: FDA