On Wednesday, the Food and Drug Administration (FDA) released an inspection report about the operations of a drug manufacturing plant that caused the ruin of millions of Johnson & Johnson’s vaccine doses.
Completed on Tuesday, the inspection revealed several observations regarding whether the said plant met FDA requirements and standards, as per the statement of Commissioner Janet Woodcock of the FDA.
The said report was 13 pages long. It revealed that the Emergent Biosolutions Bayview plant located in Baltimore was too small. Inspectors described the place as poorly designed and filthy. They also found unsealed bags of medical waste, as well as paint chipping off and damaged floors and walls.
Apart from this, they also observed that the employees did not receive proper training. They also saw that workers had failed to handle ingredients properly. The report said that the company failed to provide training to personnel involved in manufacturing, quality control, engineering operations, and more.
The agency had asked the manufacturing plant to stop operations while they conducted the inspection. The FDA also noted that it has yet to allow the plant to make and distribute the J&J COVID-19 vaccine or its components. Additionally, the vaccines distributed in the US did not come from this plant. Also, 7 million doses of the said vaccine were made in European plants.
FDA Found Numerous Issues With Emergent Manufacturing Plant
The materials manufactured at the Emergent plant have been stored while waiting for the FDA’s authorization. The issues brought about by the plant are not the only ones that the company is facing. Its distribution has also been paused as investigations on instances of rare blood clots are ongoing.
This inspection report surfaces as public health officials work to win over vaccine hesitancy. Millions of people in the US are still worried about its safety and effectiveness.
Emergent Solutions has released a statement, saying it remains committed to working with the agency and J&J to address the issues.
Meanwhile, Johnson & Johnson vowed to “exercise oversight authority” that would make sure the agency’s observations will be addressed in a timely manner. The company also said it would work toward getting Emergency Use Authorization for drug substances made at the plant.
Emergent is a company that had been manufacturing vaccines for AstraZeneca and J&J. It’s been receiving attention this year after problems surfaced when workers mixed up the ingredients needed for the two vaccines. This led to a batch of shots being wasted.
According to the company, their “rigorous quality checks” found that one batch of drug substance they had identified did not meet the required specifications.