Biologics

FDA: Multiple Violations at O3UV

An 8/23-8/31/2023 FDA inspection at the O3UV facility in Grand Ledge, MI, documented multiple violations in the firm’s illegal manufacturing of autohemotherapy devices. A 7/7 Warning Letter says the firm’s products are adulterated because the company does not have an approved PMA or IDE for them. The products are misbranded, it says, because O3UV did not notify FDA of its intent to introduce the products into interstate commerce or commercial distribution, did not comply with the Unique Device Identification regulations, and did not register with FDA as a medical device establishment.

The letter also identifies these current good manufacturing practice (CGMP) violations:

failure to establish and maintain procedures to control the design of the device to ensure that specified design requirements are met;
failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
failure to establish and maintain procedures to ensure that all purchased or otherwise received products and services conform to specified requirements;
failure to establish and maintain procedures for implementing corrective and preventive action;
failure to establish and maintain procedures for acceptance activities;
failure to establish and maintain procedures to ensure that Device History Records for each batch, lot, or unit are maintained;
failure to establish procedures for quality audits and to conduct such audits to assure that the quality system is in compliance; and
failure of the management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures.

FDA says the firm’s response to the form FDA-483 observations was inadequate. O3UV was told to respond with a list of specific steps it has taken to address violations and prevent their recurrence, with documentation of each step and a schedule for completing the corrections.

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