MDR and QS Violations at Smiths Medical

A 2/23-3/30 FDA inspection at Smiths Medical ASD, Minneapolis, MN, determined that the firm is a specification developer and manufacturer for a variety of medical devices including blood warmers and infusion pumps. A just-released 10/1 Warning Letter says the inspection found that the firm’s devices are misbranded because Smiths refused or failed to furnish required Medical Device Reporting (MDR) information. Specific MDR violations were: 

·         failing to submit a report to FDA no later than 30 days after the day the firm received or otherwise became aware of information from any source reasonably suggesting that a device that the firm markets had malfunctioned and this device or a similar device that it markets would be likely to cause or contribute to a death or serious injury if the malfunctions were to recur; and

·         failing 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 that may present a risk to health.

The letter says the inspection also determined that the firm’s devices are adulterated due to these Quality System Regulation violations: 

·         failing to establish and maintain design validation procedures to ensure that devices conform to defined user needs and intended use, including testing of production units under actual or simulated use conditions, including software validation and risk analysis, and documentation of the results in the design history record;

·         failing to establish procedures for corrective and preventive actions, with documentation of results;

·         failing to adequately establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit; and

·         failing to establish and maintain a design history file for each type of device to demonstrate the design was developed following the approved design plan and regulatory requirements.

FDA acknowledges the firm’s responses indicating it has implemented corrective actions and says the effectiveness of the corrections will be evaluated during its next inspection.

Smiths was told to take prompt action to correct the violations and prevent their recurrence and to respond with a list of specific actions it has taken, with documentation of the corrections or corrective actions and a timetable for completing the work.