Because of the pandemic, most auditors drew their conclusions from documents and video tours, during which emerging workers controlled camera angles, said a former company employee.
Johnson & Johnson auditors said the monitoring reports for bacteria or other contaminants were filed four to six months late. AstraZeneca said that Emergent has repeatedly loosened its monitoring criteria to appear to meet them, using measures such as “historical averages”. But he still failed testing, the report said.
In another audit, BARDA officials documented similar concerns, classifying 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 avoid confusion or contamination”.
The reports echoed deficiencies in quality control documented in an April inspection by the FDA, previously reported by The Associated Press, which concluded that the facility “was not ready for commercial operations”.
Several audits highlight how poorly the company was prepared for the huge workload it accepted.
Covid-19’s projects required much more testing to ensure that the materials remained stable, but Emergent had only one employee coordinating everything, the BARDA audit found. Emergent recognized at the time that its testing system “was not ideal” and committed to training at least one more Emergent worker and hiring a third party. BARDA did not respond to requests for comment on its audit or any of the others, in addition to saying that it had “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 produce the AstraZeneca vaccine without first testing them fully. This type of shortcut, called conditional release of material, occurred on average twice a week in October, internal records show. The move was deemed necessary because the company was working with reduced production times, testing delays and the needs of Operation Warp Speed, the Trump administration’s accident vaccine development program. And while a manager “consciously deviated” from the standards, the report said, vaccine batches would not be released without quality and safety tests.