Devices

QS, Other Violations in Polymer Technology Inspection

David McFarland

— 2 min read
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A 1/28-2/15 FDA inspection at Polymer Technology Systems, Indianapolis, IN, found Quality System Regulation and other violations in the firm’s manufacturing of in vitro medical devices designed for point-of-care diagnosis and management of diabetes, heart disease, kidney function, and other chronic diseases. A 7/31 Warning Letter says specific violations were: 

  •          failing to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications;
  •          failing to adequately validate a process whose results cannot be fully verified by subsequent inspection and test;
  •          failing to validate where appropriate design changes before their implementation;
  •          failing to establish and maintain procedures to ensure that all purchased or otherwise received product or services conform to specified requirements; and
  •          failing to establish and maintain procedures for implementing corrective and preventive action.

The letter says the firm’s responses to the inspection observations were inadequate. In addition, FDA says one of the firm’s products is adulterated because the company does not have an approved PMA application in effect. That product also is misbranded because Polymer did not notify the agency of its intent to introduce the device into commercial distribution.

All of the firm’s devices are misbranded, FDA says, because the company failed or refused to furnish required Medical Device Reporting material or information. Specifically, the firm: 

  •          failed 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 that the firm markets has 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 malfunction were to recur; and
  •          failed to adequately develop, maintain, and implement written medical device reporting procedures.

FDA says the inspection also revealed that one of the firm’s products is misbranded in that the company failed or refused to furnish material or information related to a correction or removal.

Polymer Technology was told to respond with a list of specific steps it has taken to correct the violations and prevent their recurrence, with documentation of the steps, and a timetable for completion.

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