Devices

QS, MDR Violations at InfuTronix

A 1/29-2/15 FDA inspection at InfuTronix, Natick, MA, found Quality System Regulation and Medical Device Reporting violations in the firm’s production of infusion pumps and associated administration sets. A just-released 6/16 Warning Letter says specific violations were:

failing to analyze processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality data problems, and failing to employ appropriate statistical methodology where necessary to detect recurring quality problems;
failing to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit; and
failing to adequately review, evaluate, and investigate any complaint involving the possible failure of a device to meet any of its specifications, unless such investigation has already been performed and another investigation is not necessary.

The letter says the adequacy of the firm’s responses to the inspection observations could not be determined. The inspection also identified these Medical Device Reporting violations:

failing to submit any report required within 10 working days of initiating correction or removal; and
failing to adequately develop, maintain, and implement written medical device reporting procedures.

The firm’s administration sets are adulterated, the letter says, because InfuTronix does not have an approved PMA or IND in effect, and the sets are misbranded because the firm did not notify FDA of its intent to introduce them into commercial distribution.

Infutronix was told to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with documentation of the corrections or corrective actions, and a schedule for completing the corrections.

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