Drugs

Cerno CGMP, Misbranding Violations

An 11/13-11/17/17 FDA inspection at Cerno Pharmaceuticals, Miami, FL, found significant violations of current good manufacturing practice (CGMP) regulations and misbranding regulations in the firm’s production of finished pharmaceuticals. A 5/15 Warning Letter says the violations were:

failing to withhold from use each lot of components, drug product containers, and closures until the lot has been sampled, tested, or examined, as appropriate, and released for use by the quality control unit;
failing to follow adequate written procedures for cleaning and maintaining equipment;
failing to maintain adequate written records of major equipment maintenance and use;
misbranding Verruguin and Stamapro due to varying labeling issues.

The company’s responses to the CGMP violations were inadequate, FDA says. In the letter, the agency says that due to the nature of the CGMP violations, it recommends that the company retain a qualified consultant to assist it in meeting CGMP requirements. Cerno was told to respond with a list of steps taken since the inspection to correct the violations and prevent their recurrence, with a schedule for completion.

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