FDA Warning Letters Hit Device Makers Over CAPA, MDR Failures

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Michael Causey, Editor-in-Chief, Association of Clinical Research Professionals

Michael Causey, Editor-in-Chief,
Association of Clinical Research Professionals

It’s been a little while since we checked the FDA’s outgoing mail tray to find out what inspectors are looking for – and often finding – during their visits in the first half of 2015

We start with a rather hefty June 12 letter to AG Industries in St. Louis, hit for a number of alleged 820-related shortcomings, including:

  • Failure to promptly review, evaluate, and investigate complaints related to a Medical Device Report (MDR) review and file an MDR with the agency for what it deemed one of perhaps several “serious complaints.” FDA found AG’s response “inadequate” because the firm labeled the incident to be not life threatening, where the agency clearly has some doubts.
  • Failure to adequately validate according to established procedures for a process those results can’t be verified by additional testing.
  • Failure to adequately establish procedures for finished medical device acceptance.

FDA says about ten percent of the nearly 210 complaints the firm has received since early 2013 are still open. Specifically, it called out a complaint that AG received in August 2013.

Note: Throughout the letter FDA says AG’s characterization of its CAPA problem as minor “appears inappropriate.”

fancyFDAlogoInsulin Management System manufacturer Insulet Corporation had a relatively easier time of it in a June 5 letter. FDA hit the firm for devices it alleges are adulterated because the methods used in, or controls of, the manufacture, packing, storage, or installation don’t meet FDA good manufacturing practice (cGMP) requirements of its Quality System regulation.

FDA fired back that the firms April 16 response was not adequate and advised the firm that “regulatory action” could be initiated without further notice unless the Massachusetts-based firm takes prompt action to correct violations FDA alleges in the warning letter.

In New Jersey, FDA called out Ultrafiler-maker Nephros for alleged failure to document evaluation of its suppliers. Like Insulet, the firm was also criticized in the May 27 letter for not including required info of complaint investigations.

Bothell, Washington-based Thorn Dental Laboratory LLC was challenged in a June 2 letter of a number of CAPA-related fronts, including:

  • An inability to produce CAPA procedures for review during the inspectors’ series of inspections in February.
  • Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit.
  • Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conformed to specific requirements such as failing to maintain adequate documentation of suppliers, contractors and consultants.
  • Failure to establish and maintain procedures for finished device acceptance.
  • Misbranding its anti-snoring/sleep apnea devices.

Our final letter in this go ‘round’s review focused on Irvine, California-based Insightra Medical, maker of catheters and hernia implants. The agency said the firm’s devices are adulterated because Insightra failed to control its facilities in terms of manufacture, packing, storage, or installation.

Insightra was hit with a number of MDR shortcomings, including failure to establish internal systems that provide for “timely transmission” of complete medical device reports.

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FDA Warning Letters Hit Device Makers Over CAPA, MDR Failures
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FDA Warning Letters Hit Device Makers Over CAPA, MDR Failures
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It’s been a little while since we checked the FDA’s outgoing mail tray to find out what inspectors are looking for – and often finding – during their visits in the first half of 2015
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