Drugs

Adulterated ShangRao Hand Sanitizer

FDA says its testing of hand sanitizer manufactured by ShangRao Chunyu Technology Co., Jiangxi, China, which was detained at the border and prevented from entering the U.S., found that the product was labeled to contain 75% of the ethanol active ingredient but contained an average of only 58% ethanol.

A 2/3 Warning Letter says that in a 9/8/20 teleconference with the firm and its registered U.S. agent FDA asked for information concerning the firm’s CGMP operations, including test methods for its finished product. The letter says the test method the company submitted is unsuited for the testing of finished hand sanitizers that contain materials other than ethanol and water. “The use of this unsuitable device to test your finished hand sanitizer products violates CGMP requirements,” the agency says.

FDA recommends that the firm retain a qualified third-party consultant to evaluate its operations and assist it in meeting CGMP requirements.

FDA placed all drugs and drug products manufactured by the firm on an 11/6/20 import alert and says they may remain on the alert until there is evidence establishing that the conditions that gave rise to the appearance of a violation have been resolved and FDA has confidence that future entries will comply with the law.

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