Thermo Fisher Scientific’s (NYSE: TMO) Greenville, North Carolina, facility has come under scrutiny after a US Food and Drug Administration (FDA) inspection revealed certain production procedure issues, including the monitoring and measurement of air bubbles within syringes, according to a Form 483 document obtained by Reuters. The inspection was part of a broader audit of Thermo Fisher, which has since been resolved, related to the manufacturing of Beyfortus.
Beyfortus, an infant respiratory syncytial virus (RSV) antibody, is co-developed by AstraZeneca (NASDAQ: AZN) and Sanofi (NASDAQ: SNY). It received European Union approval in October 2022 for preventing lower respiratory tract infections caused by RSV in newborns and infants during their first RSV infection season. The drug was subsequently approved in the US in July 2023 and in China in December 2023.
The FDA has indicated that Thermo Fisher has provided information addressing several issues, including the control of bubble size and safety perspectives on permissible bubble dimensions. While most of the concerns raised during the FDA’s manufacturing audits have been addressed, the company’s actions on air bubble monitoring specifically have been highlighted.- Flcube.com
