Devices

QS Violations at DeVilbiss Healthcare

A 7/28-8/25 FDA inspection at the DeVilbiss Healthcare medical device operation in Somerset, PA, found Quality System regulation violations in the firm’s manufacturing of oxygen concentrators, nebulizers, suction units, non-continuous ventilators, and related accessories. An 11/23 Warning Letter says specific violations were:

failing to confirm that design outputs meet design input requirements during design verification testing;
failing to maintain complaint files and establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
failing to adequately establish procedures for corrective and preventive action;
failing to evaluate and investigate any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications, unless such investigation has already been performed for a similar complaint and another investigation is not necessary;
failing to establish procedures for rework of nonconforming products, including retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications, as well as documentation of the rework and reevaluation activities in the device history record, including a determination of any adverse effect from the rework upon the product;
failing to establish an internal system that provides for timely and effective identification, communication, and evaluation of events that may be subject to Medical Device Reporting (MDR) requirements; and
failing to submit an MDR report within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have malfunctioned or caused or contributed to a death or serious injury.

FDA says the adequacy of the firm’s responses to the inspection observations cannot be determined at this time.

DeVilbiss was told to take prompt action to correct the violations and to submit a list of steps it has taken or plans to take to correct the violations and prevent their recurrence, with documentation of each corrective action and a timetable for completing the work.

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