Drugs

Cerovene Cited for Repeat Manufacturing and Data Integrity Deficiencies

FDA has cited contract drug manufacturer Cerovene Inc. for repeat current good manufacturing practice (CGMP) deficiencies following a 3/16-23 inspection of its Valley Cottage, NY facility, according to a just-posted Form FDA 483. The agency documented three observations, including repeat findings involving equipment cleaning and computerized systems controls, as well as deficiencies in laboratory controls.

FDA's first observation, classified as a repeat finding, alleged that equipment and utensils were not adequately cleaned and maintained to prevent contamination that could affect the safety, identity, strength, quality or purity of drug products. Investigators reported multiple examples of apparent cleaning failures, including equipment stored directly on the floor, and white-caked residue remaining on capsule manufacturing equipment that had already been assigned "cleaned" status.

A second repeat observation focused on computerized system controls. FDA investigators said the company did not adequately control access to manufacturing and laboratory computer systems. According to the inspection report, operators shared login credentials for a mixer's human-machine interface, audit trails and alarm reports were not routinely reviewed or backed up, and an analytical balance used in quality control testing was not password protected, allowing personnel to change the system's date and time without logging in.

The third observation cited failures to follow established laboratory control procedures. During a laboratory walkthrough, investigators found numerous volumetric flasks containing expired stock and working standards, including materials used for impurity, assay, dissolution and cleaning validation testing.

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