Drugs

FDA Warns Trailer Park Drug Maker

“Your firm manufactures drug products in a kitchen,” complains a 10/13 nine-page FDA Warning Letter to Ridge Properties owner John Randall Durig in a Salem, OR trailer park. “You use household kitchen utensils and cookware, including a steel pot, blender, and kitchen spatula to mix ingredients. Our investigator observed conditions and practices that increase the risk of your drug products containing harmful and insanitary contaminants. For example, you had a window open to the outside for ventilation during production …”

According to the Warning Letter, signed by Irvine, CA District director of pharmaceutical of pharmaceutical quality operations Steven E. Porter, Durig’s business manufactures adulterated and misbranded untested nonprescription topical analgesic drug products labeled for treating bleeding wounds, bedsores, hemorrhoids and tattoo procedure pain. “We have not received a written response from your firm that provides corrective actions to the violations identified to you during the inspection,” Porter’s letter states. The inspection was conducted from 2/28 to 3/16.

It also lists violative label claims from various product Web sites allegedly maintained by Durig’s company, such as this one for Tat Balm Gel.

FDA Webview found Durig’s business location on Google Maps with a picture of a building that looks like a domestic residence inside the gateway of a large chain-link fenced trailer park.

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