Emergent Biosolutions Inc. CEO Robert Kramer assured investors that he takes “full responsibility” for woes that beset the firm after the FDA’s Form 483 found serious manufacturing problems at the Baltimore, Md.-based Bayview plant. “You have my commitment that we're going to do everything we can to resolve these issues quickly, and as safely as possible,” he said during an April 29 conference call on first-quarter financial results.
In addition to safety questions about its COVID-19 vaccine, Johnson & Johnson is facing manufacturing challenges as a key partner, Emergent Biosolutions Inc., has yet to get FDA approval to manufacture or distribute the vaccine or its components in the U.S. That approval could be awhile in coming. On April 21, a day after completing its onsite inspection of Emergent’s Bayview plant in Baltimore, Md., the FDA released Form 483 from its inspection, revealing nine observations related to cross-contamination issues, lack of employee training and poorly designed and maintained facilities.
The FDA’s 15-day deadline for responses to warning letters has long been a sore spot for device makers, who might argue that some of the more complex regulatory findings require more than 15 days to analyze and address. That same timeline was found in both the draft and final versions of the non-binding feedback guidance for device inspections despite industry’s pleas that such a tight deadline leads to rushed judgment and potentially inadequate responses by managers at the manufacturing site.