Drugs

CGMP Violations at Custom Nutraceuticals

A 1/8-1/23 FDA inspection at Custom Nutraceuticals, Commack, NY, found significant violations of current good manufacturing practice regulations for dietary supplements, rendering the firm’s products to be adulterated. An 8/6 Warning Letter says the agency has not received a response from the firm concerning the observations on an FDA-483 issued 1/23. The significant violations were:

failing to verify, for a subset of finished dietary supplement batches identified through a sound statistical sampling plan (or for every finished batch) that the finished batch meets product specifications for identity, purity, strength, and composition;
failing to establish and follow laboratory control processes that are reviewed and approved by quality control personnel for using criteria for selecting standard reference materials used in performing tests and examinations;
company quality control personnel approved and released for distribution a batch of dietary supplements that did not meet established product specifications; and
failing to suitably dispose of label and packaging for dietary supplements that are obsolete or incorrect the ensure that they are not used in any future packaging and label operations.

Custom Nutraceuticals was told to take prompt action to correct the violations and to respond with a list of specific steps taken to correct the violations and prevent their recurrence, with related documentation and a timetable for completing the steps.

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