Drugs

Multiple ‘Serious Violations’ at LifeHealth Science

An 11/25-12/11/19 FDA inspection at LifeHealth Science, Twinsburg, OH, found multiple serious violations in the firm’s manufacturing and distribution of its ORËÁ dietary supplement. A 5/15 Warning Letter says that claims on the firm’s Web site establish that the product is considered to be a drug that is intended for use in the care, mitigation, treatment, or prevention of disease.

The letter says the ORËÁ product is not generally recognized as safe and effective for its intended use and thus is considered to be a new drug that has not been approved by FDA. The product also is misbranded, the letter says.

FDA also says that even if the ORËÁ product did not have therapeutic claims that make it an unapproved new drug and a misbranded drug, the agency investigator observed violations of current good manufacturing practice requirements for dietary supplements as follows:

failing to establish product specifications for each dietary supplement manufactured for the identity, purity, strength, and composition of the finished batch of the dietary supplement;
failing to establish component specifications; and
failing to have the firm’s batch production records include all required information.

The ORËÁ product also is a misbranded dietary supplement, FDA says, and has additional violations. LifeHealth Science was told to respond outlining steps it is taking or has taken to correct the violations and prevent them from recurring, with documentation of each step and a schedule for completing the actions.

Gupta Raises Concerns About Overton’s Independence, Ideology

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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

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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