Due to the pandemic, most listeners drew their conclusions from documents and video tours, during which Emerg workers controlled camera angles, a former company official said.
Johnson & Johnson auditors said monitoring reports for bacteria or other contaminants were filed four to six months late. AstraZeneca said Emergent repeatedly relaxed the monitoring criteria so that it appeared to meet them, resorting to measures such as “historical averages.” But even then, the tests failed, according to the report.
In another audit, BARDA officials documented similar concerns, classifying some of them, including risks of microbiological contamination, as “critical.” This designation is reserved for the most serious problems which present an immediate and significant risk.
Emergent’s own internal audit in July also said the flow of workers and materials through the plant was not properly controlled “to avoid confusion or contamination.”
The reports echoed quality control deficiencies documented in an April FDA inspection, reported earlier by the The Bharat Express News, which concluded that the facility was “not ready for commercial operations.”
Several audits highlight how poorly prepared the company was for the enormous workload it took on.
The Covid-19 projects needed a lot more testing to make sure the materials remained stable, but Emergent only had one employee to coordinate everything, the BARDA audit revealed. Emergent recognized at the time that its testing system was “not ideal” and committed to train at least one more Emergent worker and hire a third. BARDA did not respond to requests for comment on its audit or any of the others, beyond saying it had “worked with Emergent to resolve the issues” raised during the FDA inspection.
Another internal investigation in August found that Emergent had approved four raw materials used to produce AstraZeneca’s vaccine without fully testing them first. This type of shortcut, known as material parole, took place on average twice a week in October, according to internal newspapers. The measure was deemed necessary because the company was working with shortened production times, testing backlogs and the needs of Operation Warp Speed, the Trump administration’s crash vaccine development program. And while one official “knowingly deviated” from standards, according to the report, batches of vaccine would not be released without quality and safety testing.