Vaccine 6080f2db61bb7

FDA: Litany of Issues at Botched-Vaccine Plant

April 22, 2021
Vaccine production has paused at Emergent’s Baltimore plant until further notice.

The FDA released an inspection report on Wednesday that detailed a multitude of process and facility problems at Emergent BioSolutions, the contract manufacturer that botched the production of 15 million Johnson & Johnson vaccine doses due to a batch mixup first reported on March 31.  

Vaccine production has paused at Emergent’s Bayview plant in Baltimore until further notice. According to the FDA, none of the COVID-19 vaccines manufactured at the plant have been distributed for use in the United States.        

Some of the problems detailed in the 12-page report were related to inadequacies in the aging manufacturing facility, including overcrowding in the warehouse, doorways too small to move containers between rooms in a way to prevent contamination, and peeling paint and damaged walls that make thorough cleaning difficult to impossible. Others involved improper training and protocols, such as employees not signing in and out as they completed procedures or moved through the plant.

The newly released inspection report is based on FDA inspector visits to the plant between April 12 and April 20 and security camera footage of the plant. Emergent manufactured both J&J and AstraZeneca vaccines in the plant. Conflation of ingredients for the two vaccines ruined the J&J batch, and the error was caught before any vaccines were shipped out.   

An initial investigation in March did not adequately consider the movements of the operator weighing and dispensing the raw materials for the botched vaccine batch, the report said. The operator entered manufacturing areas for two different vaccines and wore the same protective gown and footwear both inside and outside of the classified manufacturing area, increasing the chances for cross-contamination of vaccine materials.

The earlier investigation also did not consider the improper storage of raw materials used to manufacture the two different COVID-19 vaccines, the report stated. The report also noted that after the contamination of the raw materials from one vaccine to another was revealed, “there was no additional cleaning performed” at the plant beyond routine cleaning and “there is no assurance that other batches have not been subject to cross-contamination.”

Wednesday’s report also noted that the Emergent manufacturing facility was “not in a clean and sanitary condition,” with areas improperly cleaned and manufacturing waste being moved and stored throughout the warehouse before it was disposed of, increasing the potential for contamination. Inspectors also noted as problematic large areas of peeling paint and damage to the floors and walls of the warehouse and manufacturing areas, impeding proper cleaning.

Overall, the manufacturing facility “is not of suitable size, design and location to facilitate cleaning, maintenance, and proper operations,” the report stated.

Employees were observed removing their protective outer garments in the same area where raw materials for vaccines were staged for manufacturing, and discarding the garments in open trash receptacles. Employees also regularly did not document whether they changed protective garments and showered to prevent cross-contamination before going from the manufacturing area for one vaccine to the area of another. On one day, 13 different people entered both vaccines' manufacturing areas but only two logged that they had showered.

Employee training also fell short, the report stated: Emergent “has failed to adequately train personnel involved in manufacturing operations, quality control sampling, weigh and dispense and engineering operations to prevent cross contamination” of the two vaccines.”

Jennifer Pancorbo, a vaccine manufacturing expert who directs industry programs and research at North Carolina State University’s Biomanufacturing Training and Education Center, says that Emergent is unusual in that it was manufacturing two different COVID-19 vaccines. Vaccine manufacturing facilities “are mostly dedicated just because capacity-wise, they only have enough for one.”

Emergent’s facility may have been designed in a way that didn’t lend itself to the physical isolation of each step of the manufacturing process that vaccine manufacturing requires, Pancorbo says. When a vaccine facility is properly configured, “you cannot really by mistake go into a room that you would not intend to—once you close the door to one room, you cannot go back. There is a directional flow in which things move. And that is true for trash, is true for people, is true for components.”

“Sometimes these buildings are old,” she says. “And they were not designed so much with segregation in mind. So what organizations do is they retrofit them the best they can to provide that segregation. It can be done. But it seems that Emergent may have had a flaw in their design, and they didn’t address it thoroughly enough.”

In response to the FDA report's release, Emergent issued a statement: "We deeply value the relationship we have with our manufacturing partners and with the FDA. The FDA’s feedback will help us continue to improve and strengthen the supply chain for Johnson & Johnson’s COVID-19 vaccine. 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.

"We are exceedingly proud of our heroic workforce in Baltimore who have stepped up to work 24/7 to ensure vaccines will be produced with the highest quality and be quickly available to fight this pandemic."

About the Author

Laura Putre | Senior Editor, IndustryWeek

Focus: IndustryWeek Contributors, Leadership, Automotive
Email: [email protected]
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Twitter: @LauraPutre


Senior Editor Laura Putre manages IW contributors and covers leadership as it applies to executive best practices, corporate culture, corporate responsibility, growth strategies, managing and training talent, and strategic planning.

A former newspaper journalist, Laura has written for Slate, The Root, the Chicago Tribune, the Guardian and many other publications.

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