- Records show FDA inspected plant in northern China in April
- Plant was inspected for future shipping to U.S., Pfizer says
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.
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.
Details of the inspection were described in an FDA report called a Form 483 that was obtained by Bloomberg News. Mackay Jimeson, a Pfizer spokesman, confirmed Pfizer’s ownership of the plant.
“Pfizer has responded and addressed the issues raised during a pre-approval inspection of our manufacturing site at Dalian,” Jimeson said in an e-mailed statement. “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.”
Jimeson declined to say what products the plant manufactures. The FDA declined to comment about the report. The FDA typically conducts an inspection of a manufacturing facility before it’s allowed to ship to the U.S.
Workers at the plant also moved manufacturing records as the FDA inspectors were going through the facility, according to the FDA report. In one room, FDA officials said they found an 8-inch high stack of documents. When they returned 10 minutes later, the documents were gone. When they asked for the documents, a factory official only brought about a third of the papers back.
“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 said in the report.
The missing documents were a set of manufacturing records. Their content, including manufacturing batch numbers of drug materials, temperature and humidity conditions, and manufacturing yield, did not match the plant’s official manufacturing records that were also inspected by the FDA, according to the agency’s report. 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.
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.
In inspections of other drug plants, the FDA found issues with data integrity at manufacturing facilities owned by Zhejiang Hisun Pharmaceutical Co. and Zhejiang Hisoar Pharmaceutical Co. earlier this year. Both make main ingredients for drugs sold in the U.S. Neither company is owned by Pfizer, though Hisoar has a 20-year agreement to supply antibiotic products to Pfizer Asia Manufacturing Pte Ltd., a subsidiary of the New York-based drugmaker, according to a 2012 stock exchange filing.
Pfizer has said that it’s aware of the past problems at Hisoar, and had taken action to ensure that the quality of its finished products wasn’t impacted.
Hisun has said it’s working to fix problems at the plant. The company has said it retested the samples in question and they met standards. Hisoar declined to comment when asked by Bloomberg this month about its FDA inspection.
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.
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.
— With assistance by Hui Li, and Anna Edney