Regulators from the United States Food and Drug Administration (“FDA”) recently conducted an inspection of a Pfizer Inc. plant located in China and the results were less than stellar. The inspection was conducted before officials gave the goahead in allowing the company to ship drugs to the United States.
Specifically, during an April inspection of Pfizer’s plant in Dalian, China, FDA inspectors reported that employees used expired manufacturing materials or ones that had not been recently checked, hid quality failures and retested failing products until they passed.
The details of the inspection were recorded in an FDA report called a Form 483 that was obtained by Bloomberg News.
Pfizer spokesman Mackay Jimeson stated that, “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. 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.
According to the report, plant workers moved manufacturing records as FDA inspectors made their way through the facility. FDA officials said that while in one room, they found an 8-inch high stack of documents. When they returned the room a few minutes later, the documents were gone. When inspectors asked for the documents, a factory worker only brought about a third of the papers back.
The FDA report stated that, “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.”
The missing documents turned out to be a set of manufacturing records. The records contained manufacturing batch numbers of drug materials, temperature and humidity conditions, and manufacturing yield. Interestingly, the information contained in those records did not match the plant’s official manufacturing records that were also inspected by the FDA. On two of the “missing pages,” inspectors said they found sticky notes stating that drug manufacturing materials were expired or past the date where they needed to be retested.
FDA inspectors also observed that when tests of certain drug products failed to meet standards, the same products were re-tested until they achieved passing results. The original failures were never reported or investigated.
In addition to the problems with the drugs and quality control, he FDA inspectors also noticed that one manufacturing area had only a single, broken stand-alone toilet located about 50 yards from the aseptic manufacturing unit. Facility inspectors saw no hand washing station and an open pit that appeared to be used as a urinal.