The US Food & Drug Administration found that a Pfizer plant in Dalian, China submitted an unofficial set of records that hid quality control failures and other problems at the facility.
According to Bloomberg, which has seen the FDA report in question, the Pfizer plant submitted a set of records that did not tally with a second set of records discovered regarding the plant’s quality control and manufacturing performance.
The FDA carried out its inspection of the plant in April. Bloomberg said the agency typically conducts such reviews of facilities that are due to ship products to the US.
The FDA report said that plant employees moved certain documents during the inspection, and that once recovered, these records showed that certain materials for drug making were either expired or passed their retesting date.
These details were not included in the plant’s official manufacturing records handed to the FDA.
In a statement to Bloomberg, a Pfizer spokesperson said the company had "addressed the issues raised" by the FDA inspection.
"The issues cited in the FDA [report] do not indicate any quality or safety concerns and do not have any impact on products currently on the market manufactured at the Dalian site," the statement continued.
"Patient safety is of utmost importance to Pfizer, and Pfizer is committed to ensuring the safety and quality of our medicines."
News of such a report will be distinctly unwelcome for the pharmaceutical industry in China, which has had a fraught relationship with the authorities over the past few years.
The GSK bribery case still resonates in the market, and concerns over food and consumer product safety are a mainstay in China.
Charles Lankester, senior vice president for reputation management at Ruder Finn Asia, told PRWeek Asia that Pfizer appear to have responded well, but the company’s choice of words is revealing.
"The clue is hidden in Pfizer’s language – it’s a ‘site’. Not ‘our facility’ or ‘our premises’. A remote operation that has apparently greatly alarmed the FDA. Given the ongoing debate about supply chain integrity, I wonder if the phrase enterprise risk management is not becoming increasingly redundant."
Lankester said there is likely no doubt that Pfizer had volumes of reports that "gave them comfort all their risk boxes had been ticked", but given the FDA reported concerns with data integrity at a facility producing Pfizer products, the situation is alarming.
"Despite ever more examples of multinational companies being wrong-footed in China and elsewhere where labour and production is cheap, basic lessons seem to be permanently missed," he said. "Maybe a rather more robust approach to managing production quality at remote sites is a good place to start."