Biologics

FDA Flags Quality System Gaps at CSL Behring Site

FDA has identified deficiencies in quality system procedures at a manufacturing facility operated by CSL Behring GmbH in Marburg, Germany, following an inspection conducted in April 2024. According to a just-posted FDA Form 483 issued at the close of the inspection, investigators cited the company for failing to adequately establish procedures related to corrective and preventive actions (CAPA), a core component of quality management systems for biologics and medical device manufacturers.

The inspection focused on the facility’s handling and analysis of product complaints. FDA investigators found that the company had not fully implemented procedures requiring documentation of whether additional actions were needed after reviewing complaint data for potential trends.

In particular, the agency noted that CSL Behring did not consistently document justifications for follow-up actions after complaint analyses, as required under its own internal procedures. Investigators also cited the absence of clearly defined written procedures for complaint data trend analysis and evaluation.

Additionally, records reviewed during the inspection did not include adequate evaluation of alert limit deviations identified during complaint trend reviews, raising concerns about the firm’s ability to systematically detect and address emerging quality issues.

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