One of Thermo Fisher Scientific's largest contract drug manufacturing plants in the U.S. has repeatedly breached rules designed to ensure drugs are free of contamination, according to FDA documents. These breaches occurred over the past 10 years, including two instances in the current year.
The FDA documents indicate that the plant, which manufactures an infant RSV drug, failed to meet contamination control standards. Such regulatory non-compliance can lead to significant operational challenges, potential fines, and a review of manufacturing processes.
Repeated breaches of FDA rules raise concerns about quality control and compliance within Thermo Fisher's contract manufacturing operations. This situation could impact the company's reputation as a trusted partner in drug production and potentially affect its relationships with pharmaceutical clients.
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