FDA Report Says Pfizer Chinese Plant Hid Failures, Used Expired Ingredients
Published: Dec 08, 2015
November 2, 2015
By Alex Keown, BioSpace.com Breaking News Staff
NEW YORK – A Chinese drug manufacturing facility run by Pfizer Inc. is under scrutiny by the U.S. Food and Drug Administration (FDA) after regulators discovered the use of expired materials and a second set of quality and manufacturing records that did not match official documentation, Bloomberg reported this morning.
However, Pfizer said the issues raised in the FDA reports do not have “any impact” on products currently available to patients. A Pfizer spokesperson told Bloomberg the concerns cited in the FDA reports “do not indicate any quality or safety concerns.” What drugs or drug components manufactured at the Chinese plant were not available.
Citing a FDA Form 483 submitted to Pfizer, during an April inspection of the facility, regulators said employees “hid quality failures, used expired manufacturing materials or ones that hadn’t been recently checked, and retested failing products until they passed,” Bloomberg said. In its report, the FDA noted that some tests conducted at the Pfizer facility were re-run multiple times in order to attain favorable results if the original testing failed. Bloomberg noted federal regulators said those original failures were never investigated or reported.
The FDA report highlighted a number of concerns, including site employees moving documents around during the inspection period and placing them in odd locations, including a wooden crate in a construction area on an upper floor. The documents regulators noted were moved were manufacturing documents that included batch numbers, temperature and humidity conditions and manufacturing yield. The missing documents did not match official documents, Bloomberg reported. In its report, the FDA noted two sets of documents including sticky-notes indicating the use of expired or out-of-date drug materials.
The problems at the Pfizer site in Dalian, a port city on the northeast coast of China, are not isolated, Bloomberg reported. The FDA has noted data integrity issues at other Chinese drug-making facilities that manufacture products sold within the United States, including the Zhejiang Hisun Pharmaceutical Co. and Zhejiang Hisoar Pharmaceutical Co. Only last week, Bloomberg reported that FDA regulators inspecting the Zhejiang Hisun Pharmaceutical Co. that supplies products to Pfizer found several disturbing violations, including the removal of documentation from a computer, lost audit records and evidence that quality control staff deleted records of tests that might show a drug was impure. The Hisun plant manufactures drug components used in cholesterol and cancer medications and its U.S. customers include Pfizer and Merck & Co. , the Telegram of London reported.
According to the Institute of Medicine, China, along with India, is one of the top producers of base ingredients for drug manufacturing. In all, the FDA has barred 38 Chinese plants from exporting some or all of its products to the United States for drug manufacturing, the Telegram said.
The FDA’s report was made public while Pfizer and Allergan have been in talks over a possible merger. Pfizer, which has a market capitalization of $218.6 billion, has been hungry for an expansive acquisition since its attempt to acquire AstraZeneca PLC fell apart in 2014. The company has had an eye to relocate its headquarters to another country to take advantage of more favorable tax rates. Allergan is based in Dublin. If Pfizer moved to Ireland, its tax rate would drop approximately eight percent.
In February Ian Read, Pfizer’s chief executive officer, slammed the U.S. Tax Code as a hindrance to business. The high tax rate in the U.S. also creates an uneven playing field when it comes to acquiring other companies, Read said in the interview. He said the high tax rate prevents Pfizer from having the available finances to offer large enough bids to acquire other biotech and pharmaceutical companies.