Devices

QS Violations in Whitehall Medical Device Inspection

A 3/6-3/23 FDA inspection at Whitehall/Division of Acorn Engineering Co., City of Industry, CA, found violations of the Quality System Regulation and Medical Device Reporting regulation in the firm’s manufacturing of whirlpool immersion hydrotherapy devices and dry heat therapy devices, according to a 7/12 Warning Letter. Specific violations noted in the letter were:

failing to adequately establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
failing to investigate the possible failure of a device to meet any of its specifications where necessary;
failing to establish a design history file;
failing to adequately establish procedures for design change;
failing to adequately establish procedures for design transfer;
failing to adequately maintain a device master record;
failing to validate a process whose results cannot be fully verified by subsequent inspection and test according to established procedures;
failing to maintain a device history record;
failing of management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency;
failing to adequately establish procedures for training and identifying training needs;
failing to develop, maintain, and implement Medical Device Reporting procedures; and
failing to report no later than 30 calendar days after the day that the firm received or otherwise became aware of information, from any source, that reasonably suggested that a device the firm markets has malfunctioned and that the device or a similar device would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

The letter says the firm’s responses to the inspection observations were inadequate. Whitehall was told to take prompt action to correct the violations and to respond with a list of specific steps taken to correct the violations, with an explanation of how the company plans to prevent these or similar violations from recurring. It was told to include documentation of each step and a timetable for completion.

Gupta Raises Concerns About Overton’s Independence, Ideology

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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