The regulator’s Complete Response Letter flagged problems at a third-party fill/finish site, which Regeneron says it has already addressed. The manufacturing facility is currently awaiting reinspection.
Tag Archive for: FDA inspection
Agency inspectors found problems with record keeping and quality controls for animal experiments at Elon Musk’s Neuralink, less than a month after the startup said it was cleared to test its brain implants in humans, according to an agency report reviewed by Reuters.
Rivals Sun Pharma’s Dadra facility and Torrent Pharmaceuticals Ltd’s oncology unit are also undergoing FDA inspections, according to reports.
The regulator issued a Complete Response Letter citing “deficiencies” at the company’s Reykjavik plant, this time for its Stelara biosimilar AVT04. It’s the fourth FDA rejection for Alvotech since last year.
The U.S. health regulator did not find any misconduct at clinical sites managed by Care Access for Pfizer (PFE.N) and French partner Valneva’s (VLS.PA) trial of a Lyme disease vaccine candidate, the contract research firm stated.
U.S. drug regulators issued a report detailing quality control lapses at Novo Nordisk’s main factory in North America as early as May last year, according to the report obtained by Reuters via a Freedom of Information Act request.
Reuters was not immediately able to authenticate the report. Novo Nordisk declined to comment on the report, but said in an emailed statement that the site was “running and producing for the market”.
The factory that fills the self-injection pens for booming weight-loss drug Wegovy has repeatedly breached U.S. sterile-safety rules in recent years and staff have failed to perform required quality checks, according to a Reuters review of regulatory documents.
The health regulator flagged application deficiencies related to the FDA’s pre-license inspection of the company’s third-party contract manufacturing firms.
U.S. drug inspectors recently recorded several new quality- control problems at an Eli Lilly and Co plant that is already the subject of a federal investigation over manufacturing lapses, according to a government report reviewed by Reuters.