FDA Policy/General

Latest FDA Warning Letters

FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.

Evig LLC (dba Balance of Nature), St. George, UT (8/20/2019): FDA inspected the company 2/2019 and cited serious violations of the Federal Food, Drug, and Cosmetic Act in the firm’s manufacturing and marketing of Whole Fruit Foods, Whole Food Veggies, and Whole Food Fiber & Spice. FDA says that claims on the products’ labels and on the firm’s Web site and YouTube channel demonstrate that the products are drugs that are intended for use in the cure, mitigation, treatment, or prevention of diseases and that the products have not been approved by FDA as drugs. The agency also cited Evig over GMP violations for dietary supplements. For example, the company failed to implement a system of production and process controls to ensure the quality of the dietary supplement and that the product is packaged and labeled as specified in the master manufacturing record. To view the letter, click here.

Won Industry Co., Republic of Korea (8/29/2019): FDA inspected the company (4/2019) and found Quality System Regulation violations with its manufacturing of the Morning Life Compression Limb Therapy System. The inspection was a follow-up to a 2015 inspection and found recurring violations. For example, the company failed to adequately establish and maintain procedures for implementing corrective and preventive action. It also failed to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. To view the letter, click here.

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