Devices

QS Issues at DFI Company

A 1/6-1/9 FDA inspection at DFI Co., Ltd. in Gimhae, Gyeongsangnam, Korea, found Quality System Regulation violations in the firm’s manufacturing of Cybow reagent strips for urinalysis. A 5/6 Warning Letter says the specific violations were:

failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
failure to establish and maintain adequate procedures to control product that does not conform to specified requirements;
failure to establish and maintain adequate procedures to control labeling activities;
failure to establish and maintain adequate procedures to ensure that device history records for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record; and
failure to identify by suitable means the acceptance status of product, to indicate the conformance or nonconformance product with acceptance criteria.

The inspection also determined the company failed to develop, maintain, and implement written Medical Device Reporting procedures.

DFI was told to respond with a list of specific actions it has taken to address the 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