An inspection report indicates that Pfizer employees concealed undesirable test results, delayed government access to records and operated amid sketchy sanitary conditions at a manufacturing site in China. The allegations against Pfizer Inc. surfaced in a so-called “483 report” that detailed findings from an April inspection of a pharmaceutical plant in northeastern China. U.S. Food and Drug Administration (FDA) investigators described a number of suspicious observations, including possible cover-ups of manufacturing lapses.
According to the FDA, when Pfizer encountered “undesirable/suspect” test results, it simply performed new tests until satisfactory results were achieved. “The original test results are not reported, and no laboratory investigation is initiated,” the FDA wrote. Officials with the FDA also recounted unusual circumstances surrounding the availability of records. According to the report, investigators at one point noticed an 8-inch stack of documents in a room, then returned 10 minutes later to find that the stack had disappeared.
When the investigators requested that the records be returned, only one-third of the papers were brought back, and the rest were later discovered stashed away in a wooden crate in a construction area, the report said. Subsequent analysis of those records revealed that Pfizer’s internal documents contained conflicting data as well as references to possible use of expired ingredients, the 483 added.
Pfizer’s quality control unit was said to lack suitable oversight of records. Employees on occasion failed to document certain activities in a timely manner, according to the 483. With respect to sanitation, the FDA described a toilet area that was “in significant disrepair” and located 50 yards from an aseptic manufacturing unit. “No hand-washing station was provided [and] an open pit appeared to be used as a urinal,” the FDA stated. Generally speaking, the FDA’s questions were not all that remarkable for a production site in Asia, where drugmakers have faced a great deal of recent enforcement involving data integrity and sanitary practices. But the targeting of a company as prominent as Pfizer was unusual.
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