
FDA Shuts Down Emergent Vaccine Facility
FDA has called a halt in production of vaccine drug substance and to quarantine all remaining product at the Bayview plant.
Just two weeks after instructing Johnson & Johnson (J&J) to take over operations at Emergent BioSolution’s noncompliant Baltimore manufacturing operation, FDA has called a halt in production of vaccine drug substance and to quarantine all remaining product at the Bayview plant. FDA initiated a “for cause” inspection of the facility last week to follow-up on violations found in an inspection last year, but requested the shutdown on April 16, 2021, according to an
This latest enforcement action further muddies the supply outlook for J&J’s troubled COVID-19 vaccine, which separately is being reviewed by FDA and the Centers for Disease Control and Prevention (CDC) as to the cause of rare blood clots following vaccination. The feds had stopped distribution and use of the J&J vaccine pending further review of the safety issues. Meanwhile, Emergent evidently has produced more than 60 million doses of the J&J vaccine but cannot release the drug substance to a finish/fill operation until FDA certifies the Baltimore plant as meeting good manufacturing practices (GMPs).
FDA had cited serious quality concerns at Emergent’s Bayview plant in an inspection in April 2020,
The FDA form 483 inspection report issued a year ago described inadequate controls for computer and records systems, disregard of established test procedures and laboratory control mechanisms, failure to investigate deviations from test methods, unclear quality control unit responsibilities and procedures, and lack of employee training on current good manufacturing practices (CGMPs) . A final observation cited deficient operations to prevent contamination or mix-ups of products by having separate or defined areas for holding rejected components before disposition. FDA and other government agencies were aware of the serious quality control issues at the Emergent facility, even before the discovery that millions of doses of J&J vaccine doses had to be discarded due to a mix-up with vaccine ingredient being produced for AstraZeneca.
Even though J&J assumed responsibility for manufacturing its vaccine drug substance at the Emergent facility two weeks ago, that apparently was not sufficient time to address the systemic manufacturing issues identified by FDA. At that time,
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