Devices

QS and MDR Violations Found at Vidco

David McFarland

— 2 min read
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A 1/3-1/12 FDA inspection at Vidco, Inc., Beaverton, OR, found Quality System and Medical Device Reporting regulation violations in the firm’s manufacturing of patient monitoring devices including the NetViewer MDP2040-0100 device, according to a 5/5 Warning Letter from the agency’s Seattle District Office. Specific violations included: 

  •          failing to establish and maintain procedures for validating the device design to ensure that devices conform to defined user needs and intended uses;
  •          failing to establish and maintain procedures for verifying the device design to confirm that the device design meets the design input requirements;
  •          failing to establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the device’s intended use;
  •          failing to establish and maintain procedures for implementing corrective and preventive action;
  •          failing to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
  •          failing to maintain device master records;
  •          failing to submit a report to FDA 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 it markets may have caused or contributed to a death or serious injury;
  •          failing to submit a report to FDA no later than 30 calendar days after the day the firm received or otherwise became aware of information from any source that reasonably suggested that a device the firm markets had malfunctioned and that this or a similar device it markets would be likely to cause or contribute to a death or serious injury if the malfunction were to recur; and
  •          failing to adequately develop, maintain, and implement written medical device reporting procedures.

The letter says the inspection also determined that the firm’s Remote patient monitoring devices are misbranded because the company refused or failed to furnish material or information about the device, including failing to submit a report or correction or removal of a device initiated to reduce a risk to health posed by the device.

The company was told to respond with a list of specific steps it has taken to correct the violations along with documentation of each step and a timetable for completion.

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