Devices

Multiple Insightra Medical Violations Cited

David McFarland

— 2 min read
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A 1/21-1/27 FDA inspection at Insightra Medical Inc. in Clarksville, TN, found multiple violations in the firm’s manufacture of the Double Pump and the Ultra Intra Aortic Balloon Pump (IABP) catheter kits. A just-released 6/3 Warning Letter says the IABP catheter kit is adulterated because Insightra does not have an approved PMA or IND in effect for it. The device is also misbranded, the letter says, because the firm introduced it into interstate commerce with major changes or modifications to the intended use without submitting a new premarket notification to FDA.

The letter references an FDA 12/30/2013 final order reclassifying some intra-aortic balloons and control systems into Class 2 and requiring the filing of a PMA or a notice of completion of a product development protocol (PDP).

On 3/20/2014, the letter says, FDA sent the company a letter informing it of the final order’s requirements and clarifying the steps that Insightra had to take. “FDA has not received a notice of completion of a PDP or a PMA from your firm, nor did you notify FDA that you wish to revise your indications by submitting an add-to-file to your previously cleared 510(k),” the letter says.

The letter also lists these Medical Device Reporting (MDR) violations:

  • failure to adequately develop, maintain, and implement written MDR procedures;
  • failure to submit a report to FDA no later than 30 days after the firm received or otherwise became aware of information, from any source, that reasonably suggests that a device marketed by the company may have caused or contributed to a death or serious injury;
  • failure to submit a report to FDA no later than 30 days after the firm received or otherwise became aware of information, from any source, that reasonably suggests that a device the firm markets malfunctioned and that device or a similar device would be likely to cause or contribute to a death or serious injury if the malfunction were to recur;
  • failure to adequately document corrective and preventive action activities;
  • failure to adequately maintain complaint files;
  • failure to adequately establish and maintain procedures for the identification, documentation, validation or, where appropriate, verification, review, and approval of design changes before their implementation; and
  • failure to submit any report required by regulations within 10 days of initiating a correction or removal.

Several of the MDR observations were repeated from a 2015 inspection, the letter says.

Insightra was told to correct all violations promptly 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 a schedule for completing them.

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