EIRs/483s

Latest FDA Warning Letters

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

Changzhou Jintan Qianyao Pharmaceutical Raw Material Factory, Changzhou City, China (5/11):FDA inspected the firm in February and documented significant GMP deviations associated with its active pharmaceutical ingredients. For example, the firm failed to implement a system for managing quality encompassing the organizational structure, procedures, processes and resources. Before 8/2016, the firm did not have any quality-related procedures in place even though it was manufacturing and shipping drugs to the U.S. Also, the firm failed to have laboratory control records that include complete data derived from all laboratory tests conducted to ensure compliance with established specifications and standards.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm558917.htm

Formulife, Inc. Allen, TX (5/12): FDA inspected the firm’s dietary supplement facility in Dallas, TX and found a number of GMP violations. Based on claims on the company’s Web site, its product Organ Shield is considered an unapproved new drug. For example, one claim stated: “silymarin [an ingredient in the product] … is comprised of several flavonolignands that help repair liver cells damaged by toxins…”
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm558916.htm

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