Devices

Multiple Violations in Abiomed Inspection

David McFarland

— 2 min read
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A 3/1-4/13 FDA inspection at Abiomed in Danvers, MA, identified multiple violations in the firm’s manufacturing of several Impella pump Class 3 medical devices. A just-released 9/19 Warning Letter says the inspection found that the Impella Connect System device is adulterated because the company does not have a PMA or IND in effect for it.

FDA says the firm’s 5/5 response to this observation is not adequate because it states that the device functions of the Connect system are Non-Device Clinical Decision Support software functions that are not subject to the PMA requirement. FDA says it disagrees with Abiomed’s analysis and finds that there are some functions of the Connect system that meet the legal definition of a medical device and thus are subject to premarket authorization.

The letter says FDA found the firm’s devices are adulterated due to these Quality System regulation violations:

  • failing to identify the actions needed to correct and prevent the recurrence of nonconforming products and other quality problems;
  • failing to verify or validate the corrective and preventive action to ensure that each action is effective and does not adversely affect the finished device; and
  • failing to establish and maintain procedures for receiving, reviewing, and evaluating complaints to assure that complaints are evaluated to determine whether the complaint represents an event that is required to be reported to FDA.

The firm’s pumps are misbranded, FDA says, due to these significant Medical Device Reporting violations:

  • 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 suggests that a device the firm 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 suggests that a device the firm markets may have malfunctioned and this device or a similar device the firm markets would be likely to cause or contribute to a death or serious injury if the malfunction were to recur;
  • failing to report a correction or removal conducted to reduce a risk to health posed by a device to FDA within 10 days of initiating the correction or removal; and
  • failing to submit a written report to FDA within 10 days of initiation of specified technical bulletins/product updates.

Abiomed was told to take prompt action to address violations listed in the letter and to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with documentation of the corrections and/or corrective actions, and a schedule for completing the corrections.

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