An FDA 483 form says the factory in Dalian, north China, hid some of its quality and manufacturing records from visiting inspectors, as well as using expired or not checked manufacturing materials, and retesting products until they passed tests without reporting failures, Bloomberg News reports.
Documents ‘inside a crate’
According to the alleged document, FDA visitors who noticed a pile of paperwork had been moved during their inspection received back only one third of the stack from a plant official.
“We then requested an interview with the individual responsible for the removal of the documents, and found that he had removed the remaining 2/3 stack from the manufacturing area and placed them in the upper-floor construction/expansion area within a wooden crate,” FDA inspectors are reported to have written.
The missing documents were a set of manufacturing records, the FDA said, including batch numbers and data on yield, temperature and humidity. They did not match the official records also seen by the FDA, the agency said. “On two pages from the set of records that had gone missing, inspectors said they also found sticky notes stating that drug manufacturing materials were expired or past the date where they needed to be retested,” Bloomberg reported.
‘One toilet’ and ‘an open pit’
“The FDA inspectors also noticed that one manufacturing unit had only one stand-alone toilet in significant disrepair 50 yards from the aseptic manufacturing unit. Inside the facility inspectors saw no hand washing station and an open pit appeared to be used as a urinal,” added the news agency, which claims to have seen the 483.
When in-PharmaTechnologist.com reached out to Pfizer, the company told us the 483 was not a quality or safety matter:
“Pfizer would like to make it clear that we did not use any expired materials in manufacturing at the Dalian site and that all products released in market from Dalian met every national and international testing specification.
"Pfizer has responded and addressed the issues raised during a pre-approval inspection of our manufacturing site at Dalian. The issues cited in the FDA Form 483 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. Patient safety is of utmost importance to Pfizer, and Pfizer is committed to ensuring the safety and quality of our medicines.”