Pfizer Plant Boosting Vaccines Has Repeat Quality Offenses

(Bloomberg) -- 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 obtained by Bloomberg via a Freedom of Information request. 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 by regulators. And the plant failed to properly sample drug products to ensure they didn't have excessive levels of certain toxins, the inspectors wrote.

The McPherson plant has previously drawn fire from regulators for drug-quality problems. 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.

Pfizer said Thursday that following the January 2020 inspection, it immediately developed and implemented a “robust corrective and preventive action plan” to address the FDA's findings.

“As of today, the McPherson site's plan remains on track, with nearly all of the improvements completed,” Pfizer spokeswoman Sharon Castillo said in a statement. “We place the utmost emphasis on patient safety and product quality at every step in our manufacturing processes.”

Pfizer's increase in vaccine production capacity was heralded last month when President Joe Biden visited the company's Michigan plant. Pfizer Chief Executive Officer Albert Bourla said then he expected the drugmaker to double its manufacturing capacity. The company plans to supply the U.S. with 200 million doses of its two-shot vaccine regimen by the end of May.

Pfizer acquired the Kansas plant in 2015 when it purchased Hospira Inc., a maker of generic drugs. Some of Hospira's problems predate Pfizer's ownership but have continued under its leadership. In response to the Freedom of Information request, the FDA said it didn't have any more recent inspection reports for the factory. It's unclear whether the FDA subjected the site to any further scrutiny before the plans to increase vaccine production there were announced.

The FDA said in a statement Thursday night that when it cleared Pfizer's vaccine for emergency use it “used all available tools and information to assess compliance with current good manufacturing practice requirements for each manufacturing site and included several conditions in the letter of authorization to ensure compliance.”

‘Severe Risk'

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 for Gilead Sciences Inc.

Pfizer will conduct the final stage of vaccine production at the Kansas factory, in which the shot is put into vials, packaged and shipped for distribution. The company developed the vaccine with German drugmaker BioNTech SE.

FDA's 2017 warning letter to Pfizer cited “significant violations of current good manufacturing” rules, including practices that could have contaminated sterile products. The agency said Pfizer failed to respond appropriately after drugs were found to be contaminated with cardboard and other particles.

The contaminants represented “a severe risk of harm to patients,” according to the letter. The cardboard was found in the antibiotic vancomycin, and Pfizer didn't recall the drug until four months after an initial complaint. In January 2020, FDA inspectors found Pfizer had released vancomycin for sale after some vials were determined to contain residues, the specific type of which were redacted.

During the FDA's visit in 2018, it found that Pfizer had turned up mold in the factory stemming from product residue on the machinery. The company blamed it on inadequate cleaning but then found residue in the same area again months later. FDA inspectors found at their 2020 inspection that Pfizer “continues to recover bacterial and/or mold isolates from critical zones.”

The most recent inspection also found that the company's testing for endotoxins in drugs including morphine and the cancer drug Nivestym wasn't adequate. Endotoxins are created by certain bacteria and in some forms, such as E. coli or botulism, can lead to serious conditions or even death.

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