Sun Sentinel Palm Beach Edition
Firm in J&J vaccine mix-up cited in past, records show
The company at the center of quality problems that led Johnson & Johnson to discard 15 million doses of its coronavirus vaccine has a string of citations from U.S. health officials for quality control problems.
Emergent BioSolutions, a little-known company vital to the vaccine supply chain, was a key to Johnson & Johnson’s plan to deliver 100 million doses of its single-shot vaccine to the United States by the end of May.
But the Food and Drug Administration repeatedly has cited Emergent for problems such as poorly trained employees, cracked vials and problems managing mold and other contamination around one of its facilities, according to records obtained by The Associated Press through the Freedom of Information Act. The records cover inspections at Emergent facilities since 2017.
Johnson & Johnson said Wednesday that a batch of vaccine made by Emergent at its Baltimore factory, known as Bayview, cannot be used because it did not meet quality standards. It was unclear how the problem would affect future deliveries of J&J’s vaccine. The company said in a statement it was still planning to deliver 100 million doses by the end of June and was “aiming to deliver those doses by the end of May.”
J&J locked arms with Emergent in April 2020, enlisting the lesser-known company to manufacture the vaccine J&J was developing with federal money.
The FDA inspected Emergent’s Bayview plant in April 2020, just as the agreement with J&J was being announced. The federal agency criticized Emergent for problems with its testing of a potential treatment for anthrax, according to the records obtained by the AP. The FDA’s lead investigator cited the company for failing to train employees “in the particular operations they perform as part of their function and current good manufacturing practices.”
The FDA’s inspection of Emergent’s Bayview plant also faulted the company for a series of quality control shortcomings, according to the records. Although the inspection was not triggered by work on a COVID19 vaccine, the issues listed by agency inspectors stand out due to the large role Emergent would soon have to combat the pandemic.
The FDA criticized the Bayview plant for failing to ensure that electronic data generated through testing of drug ingredients “was protected from deletion or manipulation.”
Emergent also did not follow proper testing and lab procedures at Bayview, the FDA said, noting that “deviations from test methods are not investigated, and are manually corrected days after performance, with no supporting data or documented justification.”
The FDA also criticized Emergent for carelessness in the handling of rejected materials in the Bayview plant. An inspector observed items in a “reject cage” that did not have reject labels, and wrote that “separate or defined areas to prevent contamination or mix-ups are deficient.”
The inspection was the most recent in a series of critical reports from the FDA about Emergent, including one following a December 2017 inspection at a plant in Canton, Massachusetts, in which the FDA said the company had not corrected “continued low level mold and yeast isolates” found in the facility.
In September 2018, agency investigators questioned why Emergent had “an unwritten policy of not conducting routine compliance audits” at a separate plant in Baltimore, known as Camden, where an anthrax vaccine, BioThrax, is filled into vials.
The FDA declined requests to discuss the inspections at Emergent’s facilities.
Emergent spokesman Matt Hartwig said the company’s “rigorous quality checks” identified a batch of drug substance that did not meet its standards. “Discarding a batch of bulk drug substance ... does occasionally happen during vaccine manufacturing, which is a complex and multi-step biological process,” he said.