Thermo Fisher plant making infant RSV drug breached FDA rules - Reuters

Investing.com -- One of the biggest contract drug manufacturing plants in the US owned by Thermo Fisher Scientific (NYSE:TMO ) has repeatedly broken rules designed to ensure that medications are free of contamination, Reuters reported on Friday.

Citing documents from the US Food and Drug Administration, the news service added that the most recent inspection of Thermo Fisher's Greenville facility last May found issues with manufacturing the respiratory syncytial virus treatment Beyfortus. The therapy from Sanofi (NASDAQ:SNY ) and AstraZeneca (NASDAQ:AZN ) is made for infants and toddlers.

Reuters added that, according to a report obtained via a Freedom of Information Act request, the FDA's inspection found that the manufacturing processes particularly fell short in making sure that equipment was sufficiently sterilized.

In total, the FDA audit found 17 issues surround the manufacturing of Beyfortus, including inadequate visual inspections for particulate matter in injectable drugs and a lack of studies supporting how Thermo Fisher measured thresholds for bubbles that can occur in injections. These types of bubbles can cause potentially deadly blockages in veins and arteries.

The FDA and Sanofi, which markets Beyfortus in the US, both told Reuters that the issues had been resolved to satisfy federal standards. The report also said there was no evidence the manufacturing issues had led to harming patients.

The FDA told Reuters that it had not taken or recommended regulatory or enforcement action following its audit, adding that it was not warranted at this time. The agency also said the site had adequately addressed its concerns around several matters, including safe control of bubble size.

A Sanofi spokesperson also told Reuters that the FDA had approved the Beyfortus doses before they left the plant for sale, Reuters reported.

Meanwhile, a spokesperson for Thermo Fisher said the firm has more than 1,000 regulatory inspections per year and takes regulator observations seriously, Reuters said.

Shares in Thermo Fisher were slightly lower in premarket US trading on Friday.

Source: Investing.com