Pfizer's Plant For Boosting COVID-19 Vaccine Production Has Been Rebuked For Repeat Quality Offenses: Bloomberg

Pfizer Inc’s (NYSE: PFE) McPherson, Kansas plant used to accelerate production of its COVID-19 vaccine was cited by federal inspectors last year for repeated quality-control violations, reports Bloomberg.

• The FDA inspectors visited the plant at the end of 2019 into January 2020 and found that the company released medications for sale after failing to review quality issues thoroughly that arose in routine testing.
• Additionally, the report cited bacteria and mold in supposedly sterile areas, an issue seen in previous visits to the facility.
• The plant failed to properly sample drug products to ensure they didn’t have excessive levels of certain toxins.
• The McPherson plant has previously been rebuked for drug-quality problems and received a warning letter in 2017 for issues similar to those 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 that following the January 2020 inspection, it immediately developed and implemented a “robust corrective and preventive action plan” to address the concerns.
• Pfizer’s increase in vaccine production capacity was acclaimed last month when President Joe Biden visited its Michigan plant.
• CEO 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 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.
• Price Action: PFE shares are up 0.35% at $34.32 in premarket trading on the last check Friday.