A Pfizer Inc. plant in China that was being inspected by Food and Drug Administration regulators in order to ship drugs to the U.S. kept a second set of quality and manufacturing records that didn’t match official ones, according to an FDA review of the facility.Outsourcing manufacturing to low wage parts of the world gives companies a financial advantage. It does not mean the company produces quality products. Globalization and buying on the cheap means often means companies no longer know their suppliers. Supplier issues impacted Baxter's deadly Chinese heparin (246 deaths) and Yashili's melamine tainted infant formula (sickened 300,000 babies and killed six).
During an April inspection of Pfizer’s plant in the northern Chinese city of Dalian, FDA inspectors said in their report that employees hid quality failures, used expired manufacturing materials or ones that hadn’t been recently checked, and retested failing products until they passed.
The problems the FDA said it found at the plant resemble similar issues at Chinese drug ingredient suppliers for Western pharmaceutical companies, according to FDA inspection documents, previous Bloomberg reports, and a previous interview with the FDA’s top official in China.Back to the Pfizer plant in northern China.
At Pfizer’s Dalian plant, the agency observed that when tests of drug products failed to meet standards, the same products were re-tested until passing results were achieved, and that the original failures were never reported or investigated.It' fitting as the Chinese have been pissing on U.S. consumers for years.
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.
Chinese quality is an oxymoron. As for Americans and our ability to get quality information, the FDA won't tell us which Pfizer drug this plant makes. It looks like Uncle Sam is guarding the Chinese outhouse.
A story from February 2009 spoke to the newest plant at Pfizer Dalian:
The expansion, which amounts to a whole new manufacturing plant on the site, will triple the production capacity at Dalian for cephalosporin, an important antibiotic for the treatment of a number of bacterial infections. The number of cephalosporin vials produced at the plant will increase from 5 million units to 17 million units a year to meet the demands of the domestic and international markets.The article spoke to Pfizer's quality efforts, some six years ago.
The new sterile manufacturing areas will produce sealed vials of cephalosporin powder ready for reconstitution into an injectable form. The increase in production capacity required an investment by Pfizer of $6m, which underlines its confidence in the Chinese healthcare market and its new focus on Dalian being developed into one of its larger global manufacturing sites with continued investment.
As well as opening the new facility, Pfizer has also been working with the Chinese authority to increase knowledge of the importance of drug safety and quality control.Who knew high quality supervision and quality control involved two sets of books and retesting until some segment of the production run actually met standards?
Pfizer has made an effort to share its best practices in these important fields and is also supporting the Chinese efforts in promoting the high-quality supervision of pharmaceutical products.
