FDA cites Pfizer for shortfalls at Chinese manufacturing plant

The FDA and European regulators, which have long had concerns about the quality of drugs being manufactured by Chinese companies, are now finding issues at some Chinese plants owned by Big Pharma. The FDA has cited a Pfizer ($PFE) plant in China while U.K. regulators recently found shortcomings at a GlaxoSmithKline ($GSK) plant there.

Bloomberg reports it has gotten its hands on a Form 483 issued by the FDA in April for a Pfizer plant in Dalian, where employees were keeping two sets of manufacturing records. The inspectors initially were shown an "official" set of records, but inspectors later found a second set of records hidden in a crate in a construction area. Those did not match up with the official versions, showing instead that expired ingredients had been used in some products and that employees had been retesting batches until they got the results needed for them to pass.

Inspectors also noted that in one manufacturing unit there appeared to be an open pit being used as a urinal and no handwashing station.

In a 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," the email from Jimeson said. "Patient safety is of utmost importance to Pfizer, and Pfizer is committed to ensuring the safety and quality of our medicines."

Bloomberg said Pfizer would not say what drugs were manufactured there.

The inspection of the Pfizer plant came just weeks after the FDA had also cited a plant in Taizhou operated by Pfizer joint venture partner, Zhejiang Hisun Pharma. The FDA in September issued an import alert after an inspection in March at the Hisun plant noted a "lack of integrity" the company has acknowledged. Hisun in 2012 hooked up with Pfizer in a joint venture to make and sell in China some of Pfizer's off-patent drugs.

But Pfizer is not alone is this exhibiting such shortcomings. The European Medicines Agency (EMA) recently withdrew the manufacturing certificate from a GSK plant in Tianjin, China, after U.K. regulators found "critical" deficiencies. After the inspection, GSK in August had to close the facility due to damage from explosions that impacted buildings throughout the industrial area in Tianjin where it is located.

Chinese manufacturers dominate the market for cheap active pharmaceutical ingredients but Chinese authorities have a spotty record ensuring they are safe. The FDA opened an office there to do its own inspections after Chinese-made crude heparin was tied to dozens of deaths of dialysis patients in 2008. The FDA two years ago got additional funds to expand its staff there, but China has been uncooperative about letting in more inspectors, sitting on visa applications even after Vice President Joe Biden raised the matter during a trip last year.

- read the Bloomberg story