The FDA recently banned some products from a plant operated by Pfizer joint venture partner Zhejiang Hisun Pharma after an inspection in the spring found deficiencies. Turns out weeks later, investigators showed up at one of Pfizer's own plants in China and found issues there as well.
According to Bloomberg, the FDA issued a Form 483 for a Pfizer plant in Dalian after an inspection in April. Bloomberg, which has seen the form, said investigators found that employees were keeping two sets of books about batch testing that indicated they had used some expired ingredients in production. They were also retesting batches until they got passing results. FDA inspectors discovered the data integrity issues after they found that employees hid some records in a crate in a construction area.
In an e-mailed response to Bloomberg, Pfizer spokesman Mackay Jimeson said:
"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."
Pfizer would not say which drugs were manufactured there, Bloomberg said.
The inspection of the Pfizer plant came just weeks after the FDA had discovered issues with some products at the Hisun Pharma site in Taizhou. The company acknowledged in September that the FDA had banned 15 products after an inspection in March found a "lack of integrity." Hisun hooked up with Pfizer in 2012 in a joint venture to make and sell some of Pfizer's off-patent drugs in China.
But Pfizer is not the only Big Pharma player to run into manufacturing problems in China recently. The European Medicines Agency (EMA) recently withdrew the manufacturing certificate from a GlaxoSmithKline ($GSK) plant in Tianjin, China, after U.K. regulators found "critical" deficiencies. That plant is currently closed after explosions and a massive fire in the industrial area where it is located damaged the GSK facility. GSK, like Pfizer, said it took the issues seriously and was working on resolving them.
The FDA stepped up inspections of Chinese manufacturers after Chinese-made crude heparin was tied to dozens of deaths of dialysis patients in 2008. Two years ago, Congress allocated more funds to expand FDA foreign inspection, but China has been sitting on visa applications for the extra FDA inspectors, even after Vice President Joe Biden raised the matter during a trip last year.
- read the Bloomberg story