Drugs

7 Observations in Korea’s Hugel FDA-483

FDA has released the form FDA-483 issued following an 8/12-8/20/21 inspection at the Hugel drug substance and drug product manufacturing facility in Chuncheon, Gangwon, Korea. The seven inspection observations were:

Clostridium botulinum spore containment in the drug manufacturing areas is inadequate to mitigate spore cross-contamination risk in other manufacturing areas;
decontamination of Clostridium botulinum spores and toxin in the drug substance manufacturing area is inadequate;
environmental monitoring is insufficient to ensure that the drug product manufacturing areas are not contaminated with Clostridium botulinum spores as Clostridium spores are not monitored as part of environmental monitoring;
investigation of out-of-specification DV19-019 for identification and purity by SDS-PAGE is inadequate;
the standard operating procedure for logbook preparation and management was not updated promptly to include adequate controls to prevent the loss of logbooks;
the working cell bank lot used to manufacture the drug substance lots and submitted in [redacted] is different from a working cell bank lot number used to manufacture a [redacted] drug substance during inspection; and
a heavily redacted observation involving a drug product batch exceeding the specified filling time.

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