Drugs

Multiple Violations at Images Unlimited Products

An FDA 8/9-8/21/19 inspection at Images Unlimited Products, doing business as Cellect Products & Oglethorpe, as well as an agency review of labels for the firm’s products and a Web site, found serious violations of the Federal Food, Drug, and Cosmetic Act and applicable regulations. A just-released 3/20 Warning Letter covers unapproved new drug and misbranded drug violations and adulterated dietary supplement current good manufacturing practice (CGMP) violations.

The specific CGMP violations listed in the letter were:

quality control personnel approved and released for distribution a batch of dietary supplement that did not meet established product specifications;
failing to prepare a batch production record every time a batch of dietary supplement is manufactured; and
failing to prepare and follow a master manufacturing record for each unique formulation of a dietary supplement to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record.

The letter also lists misbranded dietary supplement violations.

Images Unlimited was told to respond with a list of specific steps taken to correct the violations and prevent their recurrence, with copies of related documentation and a schedule for completing the actions.

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