FDA raises several concerns with Emergent BioSolutions following inspection

Posted at 11:57 AM, Apr 21, 2021
and last updated 2021-04-22 09:40:26-04

WASHINGTON — Dirty conditions, potential cross contamination and ill trained employees… those are just some of the red flags raised by the FDA after an 8-day inspection at Baltimore’s Emergent BioSolutions, the primary manufacturer for the Johnson & Johnson and AstraZeneca vaccines in the U.S.

As part of the inspection, the FDA "reviewed the quality of manufacturing procedures, including records, staff training, facility operations, drug production and testing and the systems in place to ensure product quality."

It resulted in nine specific concerns being raised.

Inspectors cited the company's "failure to conduct thorough investigation into unexplained discrepancies."

They found that the building where vaccines were being manufactured was "not maintained in a clean and sanitary condition," and "not of suitable size, design, and location to facilitate cleaning, maintenance, and proper operations." The equipment too was not of adequate size to facilitate operations.

Additionally, inspectors say procedures were not followed to prevent cross-contamination in "production and process control functions" and the "product containers or closures were not handled or stored in a manner to prevent contamination." Neither was the equipment or utensils used, according to the report.

Inspectors wrote there was inadequate documentation that is supposed to be kept to assure the substances manufactured at the facility have the "identity, strength, quality, and purity represented."

Even more, employees at the facility were apparently "not trained in the particular operation they performed."

The FDA examined security camera footage from the last four months and documented eye witness accounts during the inspection.

The findings are the latest setback for Emergent, which so far has not received FDA approval to publicly distribute any of its manufactured vaccines.

Last year, Emergent BioSolutions received $628 million from the federal government to establish a primary U.S. facility for manufacturing the Johnson & Johnson and AstraZeneca vaccines. The Baltimore location is a proposed facility and this inspection was part of the FDA's review process.

U.S. Johns Hopkins professor Dr. Anna Durbin said while the findings are concerning, they are also promising.

"This is another example that we do have regulations and we do have processes in place that ensure that the vaccines that are produced are high quality, that they are safe," said Durbin.

Emergent BioSolutions has agreed to pause new production while it works with the FDA to resolve the issues.

According to the FDA, "the vaccines already manufactured 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."

RELATED: FDA requests Emergent BioSolutions pause J&J vaccine distribution as investigation gets underway

Last month, reports surfaced that Johnson & Johnson installed a new leadership team to oversee all aspects of production and manufacturing at the facility after they accidentally ruined 15 million doses by mixing up the ingredients.

In response to the error, the Biden Administration removed AstraZeneca manufacturing from the plant.

On Tuesday, members of Congress announced an investigation into how Emergent BioSolutions ended up with a federal contract in the first place to manufacture vaccines.

READ MORE: Congress investigating how Baltimore based Emergent BioSolutions ended up with J&J vaccine contract

Since April 13, the Maryland Department of Health has directed all COVID-19 vaccine providers in the state to pause the administration of the Johnson & Johnson shot, after the FDA and CDC recommended a temporary halt following the emergence of rare and severe blood clotting in some individuals who were given the vaccine.

The FDA said their inspection had nothing to do with those issues.

After the FDA released their findings, Emergent released a statement saying the problems are fixable and will be corrected.

"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."

The company added they remain proud of their employees and their efforts.

"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."

"They will likely need to be reinspected by the FDA before any vaccine that’s produced there would be accepted and I think that’s good," said Durbin.

Read the entire inspection report below.