Drugs

Judge Orders Riddhi USA to Stop Product Sales

A New York federal judge has entered a consent decree sought by FDA against Riddhi USA, ordering the company to stop selling its products until it complies with agency dietary supplement manufacturing regulations and other conditions in the decree. An agency news release says FDA alleged that the company was selling adulterated and misbranded dietary supplements. The consent decree covers the firm and its president and owner, Mohd Alam.

The release says Riddhi USA is a manufacturer that distributes dietary supplements wholesale and does not market or advertise under its own brand. According to a complaint filed by the Justice Department for FDA, the firm’s violations included failing to establish product specifications for the identity, purity, strength, and composition of the finished dietary supplements; inadequate master manufacturing and batch production records; lack of quality control procedures; and lack of procedures to investigate product complaints. The products’ labeling also failed to declare dietary ingredients and the manufacturer’s place of business, the complaint said.

A 2016 Warning Letter issued following a facility inspection identified violations of good manufacturing practice regulations and said the company failed to declare all ingredients on its products’ labels.

Should Riddhi USA wish to resume manufacturing, the consent decree prohibits the company from receiving, processing, manufacturing, preparing, packing, holding, and distributing dietary supplements until it hires an expert to ensure that it follows all current good manufacturing practice regulations and receives FDA approval to resume operations following an agency inspection.

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