Because of the pandemic, most auditors drew their conclusions from documents and video tours, during which emerging workers controlled the camera angles, one former company official said.
Johnson & Johnson’s auditors said monitoring reports for bacteria or other contamination were submitted four to six months late. AstraZeneca’s said Emergent had repeatedly relaxed its monitoring criteria to appear to be complying with measures such as ‘historical averages’. But even then, it did not pass the tests, the report said.
In another audit, BARDA officials documented similar concerns and labeled some of them, including the risks of microbiological contamination, as ‘critical’. This designation is reserved for the most serious problems that pose an immediate and significant risk.
Emergent’s own internal audit in July also said that the flow of workers and materials through the plant was not adequately controlled “to prevent mixtures or contamination.”
The reports reflect the shortcomings in quality control that were documented in an FDA inspection in April, previously reported by The Associated Press, and concluded that the facility was “not ready for commercial operations.”
Multiple audits highlight how poorly the company was prepared for the large workload it accepted.
The Covid-19 projects required significantly more testing to ensure materials remained stable, but Emergent had only one employee coordinating it all, the BARDA audit found. Emergent acknowledged at the time that his testing system was “not ideal” and promised to train at least one more emerging worker and hire a third. BARDA did not respond to requests for comment on its audit or any of the others, except that it “worked with Emergent to resolve the issues raised during the FDA inspection.”
Another internal investigation in August found that Emergent approved four raw materials used to make AstraZeneca’s vaccine without first testing it completely. The type of shortcut, called a conditional release of material, occurred on average twice a week in October, according to internal logs. The measure was deemed necessary because the company worked with shortened production times, tested backlogs and met the needs of Operation Warp Speed, the Trump administration’s crash vaccination development program. And although a driver “knowingly deviated from the standards”, the report said the vaccine would not be released without quality and safety tests.