The factory that Pfizer Inc. plans to use to boost production of its covid-19 vaccine for the massive U.S. inoculation effort was cited by federal inspectors last year for repeated quality-control violations. Food and Drug Administration inspectors visited the McPherson, Kansas, plant at the end of 2019 into January 2020, according to an inspection report. They found the drug giant released medications for sale after failing to thoroughly review quality issues that arose in routine testing, the report shows. Additionally, the report says inspectors found bacteria and mold in supposedly sterile areas, an issue seen in previous visits to the facility. And the plant failed to properly sample drug products to ensure they didn't have excessive levels of certain toxins, the inspectors wrote. The FDA sent Pfizer a warning letter, the agency's strongest rebuke, concerning the factory in 2017 after the agency detected issues similar to those it found in 2020. The FDA concluded that Pfizer had addressed the violations in June 2018, a month before it returned to the facility and found more problems. The company plans to supply the U.S. with 200 million doses of its two-shot vaccine regimen by the end of May. The FDA halted all inspections of drugmaking facilities at the beginning of the Covid-19 pandemic, though it has since resumed some domestic visits. Pfizer's plant in Kansas is also authorized to make the Covid-19 treatment remdesivir.
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