Devices

Multiple Violations Seen in ASP Global Inspection

A 7/18-8/1/2025 FDA inspection at ASP Global, doing business as Anatomy Supply Partners in Austell, GA, found multiple violations in the firm’s manufacturing of the Safe-T-Fill Micro Capillary Collection System. A just-released 12/9/2025 Warning Letter cited these specific Quality System Regulation, Medical Device Reporting, Corrections and Removal, Unapproved Device, and Labeling violations:

failure to adequately establish procedures to ensure that all purchased or otherwise received products and services conform to specified requirements;
failure to adequately develop, maintain, and implement written Medical Device Reporting procedures;
failure to submit a written report to FDA of any correction or removal of a device initiated to remedy a violation of the Federal Food, Drug, and Cosmetic Act caused by the device, which may present a risk to health;
making significant changes or modifications to an original device that was cleared by FDA and for which the company lacks clearance or approval; and
failure of the labeling to contain adequate directions for use.

ASP was told to correct the violations promptly and to respond with a list of specific actions it has taken to correct the violations and prevent their recurrence, with documentation for each action 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