Regulatory Focus™ > News Articles > FDA Warns Medtronic Subsidiary Over Adulterated Devices

FDA Warns Medtronic Subsidiary Over Adulterated Devices

Posted 22 June 2016 | By Zachary Brennan 

FDA Warns Medtronic Subsidiary Over Adulterated Devices

Highlighting validation concerns and the distribution of adulterated devices with nonconformities, the US Food and Drug Administration (FDA) earlier this month sent a warning letter to Medtronic subsidiary Tyrx.

The letter, dated 2 June, follows an inspection of the company’s Monmouth Junction, NJ-based site from 30 November 2015 through 12 February 2016, with respect to Tyrx’s Antibacterial Envelope, Antibacterial Absorbable Envelope, which is intended to reduce the chances of device migration, erosion or Twiddler Syndrome, and the Neuro Antibacterial Absorbable Envelope. 

FDA cited the company for three violations, noting at the outset that Tyrx “failed to establish procedures for the control and action to be taken on devices distributed, and those not yet distributed, that are suspected of having potential nonconformities.”

In one specific instance, FDA’s inspectors found that the company failed to validate the effectiveness of a corrective measure to see if by updating a test method that Tyrx mitigated future incidents of impurity/related substance failures.

FDA also said it reviewed the firm’s responses to deficiencies cited and concluded “that they are not adequate. Specifically, incomplete process validations were provided in your written responses for the [redacted] for large TYRX Antibacterial (AIGIS Large Devices) Envelope, [redacted] for [redacted] after [redacted] production process, and the[redacted] Machine.” 

The agency also found that batch records for certain validation lots used to support the polymer production process for TYRX Antibacterial Envelopes documented a failure and deviations from the instructions in the batch records. 

In addition, FDA said that the company’s other responses on validation “fail to comply with 21 CFR 820.70(b) where production and process changes (changes to a specification) shall be verified or where appropriate, validated according to 21 CFR 820.75 before implementation and these activities shall be documented.”

Medtronic spokeswoman Tracy McNulty told Focus: "Medtronic confirms it has received an FDA warning letter related to its Tyrx manufacturing facility in Monmouth Junction, New Jersey. The facility manufactures the Company’s Tyrx Antibacterial Envelopes. The letter relates to process validation, corrective actions & preventive actions (CAPA), and change controls. The Company is committed to working with FDA to resolve these issues in a timely manner.  We do not expect the warning letter to have a significant financial impact to the company." 

The release of the warning letter coincides with Jeffrey Shuren, M.D., J.D., director of the Center for Devices and Radiological Health, praising the company and its founding by Earl Bakken and his brother-in-law Palmer Hermundslie in 1949 at FDA’s Celebration of the 40th Anniversary of the Medical Device Amendments on Wednesday.

Tyrx Warning Letter

Editor's note: Story updated with Medtronic comment.

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