Emergent BioSolutions to Respond to FDA’s Form 483 ‘Within Days’

The chief executive officer of troubled Emergent BioSolutions has promised to deliver “within days” the company’s response to a scathing Form 483 issued in April following a serious mix-up of vaccine materials that ruined millions of doses of Johnson & Johnson’s (J&J) COVID-19 vaccine.

The company, whose Bayview, Md., facility has stopped all production of the vaccine, has until May 12 to respond with a corrective action plan under FDA regulations.

Emergent CEO Bob Kramer said during a briefing with investors that the company is hard at work resolving the nine observations the agency documented during its for-cause inspection last month (DID, April 22).

“Our team is expected to submit, within days, a comprehensive response to [the agency’s] findings that is designed to meet or exceed the FDA standards,” Kramer said. “If the FDA is comfortable with the approach we propose, I’m hopeful that we can soon return to producing the tens of millions of doses per month.”

The company chief also touched on the issue that led to the freeze in production at the facility while it was making both the AstraZeneca (AZ) and J&J vaccine. The highly publicized incident resulted in intervention by the U.S. government, which handed the reins of the facility to J&J and forbade further AZ vaccine manufacturing (DID, April 5).

“We had implemented layers of disinfection and other protocols to lessen the inherent risk of cross-contamination. We believe that the batch was likely contaminated when one or more of these precautions did not function as anticipated, resulting in the transmission of the AZ virus to the J&J production suite,” Kramer said. “Importantly, our rigorous safety and quality protocols work as designed, identifying this contamination batch to ensure that it never left our facility.”

Adding to Emergent’s woes, two high-ranking House Democrats, Reps. Carolyn Maloney (D-N.C.) and James Clyburn (D-S.C.), have launched an investigation into the company’s federal contract to tailor its Bayview facility to produce J&J and AZ vaccines. The lawmakers allege that Robert Kadlec, a former Emergent consultant and assistant secretary for preparedness and response in the Trump administration, fought for the contract “despite indications that Emergent did not have the ability to reliably fulfill [the contract]” and had an alleged “long, documented history of inadequately trained staff and quality control issues” at the Bayview facility.

Maloney and Clyburn set a May 3 deadline for Emergent to deliver requested documents related to their inquiry. It’s unclear if the drugmaker has produced the documentation demanded by the lawmakers. — James Miessler