FDA Policy/General

Inspection Cites Thermo Fisher Manufacturing Facility

FDA has cited significant manufacturing and quality control deficiencies at a facility operated by Thermo Fisher Scientific (Patheon Italia unit) in Ferentino, Italy, following a 2/2025 inspection. The inspection identified lapses in quality unit oversight, including failures to properly document and investigate deviations, inadequate control over testing and inspection processes, and insufficient verification of sample handling and microbial testing timelines, according to a just-posted FDA Form 483.

Regulators also flagged concerns with process controls, noting the company did not adequately validate certain manufacturing steps or ensure consistent performance of critical equipment. In one instance, repeated production stoppages were not fully investigated, raising questions about process reliability and product consistency.

FDA further cited shortcomings in sterility assurance practices, including gaps in aseptic process simulations and operator training. Inspectors observed instances where sterile components may have been compromised during handling, and noted delays in implementing corrective actions for previously identified risks.

Additional observations pointed to weaknesses in visual inspection programs for injectable drug products, with inadequate training, poorly designed qualification procedures, and insufficient assurance that products are free from particulate contamination. The agency also raised concerns about environmental monitoring and cleaning practices in classified manufacturing areas, including limited sampling, insufficient validation of disinfectants, and failure to simulate worst-case conditions during qualification studies.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome