Drugs

8 Observations on Fujifilm Diosynth FDA-483

FDA has released the form FDA-483 issued following a 3/4-3/11/2025 inspection at the Fujifilm Diosynth Biotechnologies Texas drug manufacturing facility in College Station, TX. The eight inspection observations were:

failure to adequately control the multi-product manufacturing areas to prevent potential cross-contamination;
the quality control laboratory controls used for in-process, release, and stability testing of a redacted intermediate do not include appropriate testing procedures that assure conformance to appropriate standards of quality and purity;
failure to follow a specific stability testing program;
the cleaning and sanitization program is deficient in preventing potential contamination in the controlled drug substance manufacturing areas.
environmental monitoring of classified processing areas in the redacted facility for the redacted intermediate manufacturing is deficient;
failure to exercise appropriate controls for the electronic data acquisition systems used for redacted intermediate manufacturing;
SOPs or work instructions are not followed or are inadequate; and
the intermediate hold times defined in the redacted intermediate batch records are inconsistent with the hold times defined in a redacted document.

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