Thermo Fisher's Greenville plant has repeatedly violated FDA rules, raising concerns about manufacturing practices

From Investing.com: 2024-10-04 07:10:52

Thermo Fisher Scientific’s Greenville plant, one of the largest contract drug manufacturing facilities in the U.S., has repeatedly violated FDA rules aimed at ensuring drug quality over the past 10 years, including issues with respiratory syncytial virus drug Beyfortus.

FDA audit records reveal several manufacturing deficiencies, despite Thermo Fisher resolving issues to FDA’s satisfaction, including concerns with sterilization processes for important medicines like Novo Nordisk’s weight-loss drug Wegovy.

Experts raise concerns about Thermo Fisher’s quality control practices, pointing to a fix-when-caught mentality rather than a preventative culture, as highlighted by FDA findings of inadequate sterilization and handling of sterile components like injectable drugs.

A recent FDA audit at Thermo Fisher’s Greenville plant flagged multiple issues during the inspection of the Beyfortus production line, including shortcomings in required manufacturing processes, such as visual inspections for particulate matter and staff handling of sterile components like sterile equipment.

The FDA report noted 17 issues during the Beyfortus audit, including lack of studies supporting the measurement and thresholds for bubbles in injectable medicine, which could pose serious health risks, although the FDA did not recommend any regulatory or enforcement actions at this time.

Thermo Fisher’s plant had not provided sufficient proof backing up its measurement and thresholds for bubbles in injectable medicine, which can lead to deadly blood blockages. FDA encourages cooperation from companies on these matters to ensure patient safety and quality control compliance.

The FDA highlighted concerns regarding issues of microbial contamination in FDA audits in the past 10 years, with expert reviewers expressing worry over inadequate sterilization processes and containment measures to prevent leakage of drugs.

Thermo Fisher’s Greenville plant was inspected by the FDA multiple times over the years, with five audits raising concerns about manufacturing practices, including microbial contamination prevention and sterilization procedures for equipment used in drug production.

Despite multiple FDA audits identifying manufacturing concerns, Thermo Fisher’s Greenville plant continues to operate, producing a range of medicines, including vaccines during the flu season, although Thermo Fisher’s vaccine production for COVID and flu vaccines wasn’t part of the recent FDA inspections.

Thermo Fisher has received substantial government funding, including $49 million from the U.S. Department of Defense in 2020, to support COVID vaccine production at its Greenville plant, a key facility within its global manufacturing business that contributes significantly to the company’s overall revenue.



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