FDA inspection report casts doubt on J&J vaccine contractor's ability to restart production

The FDA report describes Emergent’s vaccine facility as “overcrowded” and “overloaded,” resulting in piling up of various materials nearby and difficulty navigating the floor without bumping into equipment. The inspectors also found that paint was peeling on walls and floors and that waste in the facilities was not properly decontaminated.

Emergent said it is working with FDA and J&J to resolve the issues quickly. “While we are never satisfied with defects in our production facilities or processes, these can be corrected and we will quickly take action to correct them,” the company said in a statement.

It added that “It is normal for the FDA to issue findings after an inspection of the facility and provide instructions for the steps necessary to improve operations.” It’s rare, however, for the agency to move so quickly – release a report of an inspection that was completed just the day before – and accompany its findings with a statement from senior FDA officials.

Johnson & Johnson has relied on Emergent to help meet its goal of shipping 100 million doses to the federal government by June, although production pressures have eased since the company’s rare-occasion use of the company’s vaccine for an unrelated probe Severe blood clot was interrupted. J&J also hired pharmaceutical giant Merck to make vaccines. However, Merck’s production facility will not be operational until the second half of the year.

A second Merck facility on board, filling vials with the J&J vaccine and completing the packaging jars, is unlikely to begin production without delivering vaccine from Emergent, said a person aware of the situation. The person and another person familiar with the FDA process said it could take months to resolve some of these issues.

In a statement, Johnson & Johnson said it will work to resolve the issues identified in the FDA inspection report and will continue to obtain emergency clearance for Emergent that would allow the company to manufacture J & J’s vaccine.

However, J&J also announced that it is building a “global vaccine supply network” that includes a manufacturing facility in Leiden, the Netherlands, which already produces Covid-19 vaccines, as well as ten other unspecified manufacturing facilities.

“We are working around the clock to develop and fully activate our production capacities for the global delivery of our COVID-19 vaccine,” said the company.

The FDA has released its latest version Inspection report just a day after that Investors said they would sue Emergent for failing to disclose production issues that resulted in ingredient mix-up that ruined 15 million J&J shots. Federal regulators ordered AstraZeneca to leave the Emergent factory in March, citing the manufacturing accidents.

The Agency also inspected Emergent’s facilities in February and October, but it is unclear whether the extent of these issues was spelled out in previous reports.

The FDA “takes its responsibility to ensure the quality, safety and efficacy of medical devices very seriously,” said Acting Commissioner Janet Woodcock and the agency’s vaccines chief Peter Marks in a joint statement. “The American public trusts the Agency to ensure that all medical products, including COVID-19 vaccines, meet the Agency’s standards for quality, safety and efficacy.”

The FDA, which said they are working with Emergent to resolve the issues, must re-examine the facility and fully test the batches before clearing the cans for clearance.

Woodcock and Marks said in their statement that all cans already made will undergo additional testing, but the release is not yet clear. Doses made by Emergent are not intended for emergency use, therefore none have been used by the public.

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