FDA alleges major violations, use of old ingredients at Chinese Pfizer plant
- During an inspection of one of Pfizer's plants in China in April, FDA inspectors turned up quality failures and use of expired materials at a plant in Dalian, according to a report from Bloomberg.
- Pfizer responded to the findings by saying that it had addressed all of the quality-related issues that came up during the inspection.
- Neither Pfizer nor the FDA would comment on which drugs are manufactured at the Dalian facility.
Here are some of the specifics of the problems the FDA found: hidden quality failures in which workers tested and retested products until they passed; use of expired materials or ones that had not recently been checked; documents that had been moved by workers while the FDA inspectors were onsite; and intentionally misleading FDA inspectors.
One of those violations alone would be concerning, but combined, they are truly worrisome. Pfizer, for its part, says that it is aggressively taking measures to correct the numerous problems.
This is part of a broader manufacturing problem that biopharma has when it comes to the use of international plants. As BioPharma Dive has previously reported, the FDA regularly finds irregularities and violations at plants in India, and authorities in the U.S. and Europe have gone so far as to put huge numbers of drugs on do-not-import lists.