Drugs

Multiple Violations at Professional Compounding Centers

A 10/22-10/29/20 FDA inspection at Professional Compounding Centers of America, Houston, TX, found multiple significant violations, including deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API). A 1/27 Warning Letter says CGMP violations identified at the company’s suppliers caused drugs manufactured by those firms to be adulterated. Specific violations listed in the letter were:

receipt of adulterated drugs;
adulteration and misbranding of glycerin API; and
misbranding due to false or misleading labeling of drug products.

The company was told to respond with a list of steps taken since the inspection to address the deviations and violations and prevent their recurrence, including a schedule for completing the actions.

It also was told to schedule a regulatory meeting with FDA to discuss the adequacy of the corrective actions it proposes to prevent the continued introduction of adulterated and misbranded goods into interstate commerce. Topics for the regulatory meeting are to also include supply chain controls and compliance with CGMP.

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