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.

BHP Holdings, Woodinville, WA (6/17): FDA inspected the company 10/2019 and cited GMP violations for dietary supplements. For example, BHP failed to review all product complaints to determine whether they involve a possible failure of a dietary supplement to meet any of its specifications. Additionally, the company was cited over misbranding due to noncompliance with labeling requirements. To view the letter, click here.

KBMO Diagnostics, Hopedale, MA (6/17): FDA recently reviewed the company’s Web site and determined that its “Covid-19 Fingerstick Test Kit” is offered for sale and distributed in the United States for at-home use without marketing approval, clearance, or agency authorization. The letter also said the device is misbranded because the Web page uses the FDA logo, which should not be used in private-sector materials. To view the letter, click here.

Nanobots Healthcare, Houston, TX (6/12): FDA inspected the firm 11/2019 and cited serious deficiencies in its practices for producing sterile drug products. For example, sterile products were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health. The company also failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area. Additionally, media fills were not performed under the most challenging or stressful conditions. 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