The manufacturing facility involved in this recall is the Boston Massachusetts facility acquired in 2015 via Integra’s takeover of TEI Biosciences.
All four recalled products mentioned in the news release – SurgiMend, PriMatrix, ReVize and TissueMend – were developed by TEI BioSciences.
PolyNovo’s principal competitor product, Integra Dermal Regeneration Template, would not be manufactured at this facility and so would not be impacted by this product recall.
There have been long-standing problems at the Boston Massachusetts facility, as disclosed in Integra’s Quarterly report last month (as well as prevous SEC filings). The latest FDA inspection of this facility occurred in March this year (prior FDA inspections have led to Warning Letters) and although Integra stresses in its announcement this week that the recall is voluntary, one gets the sense (see highlighted section below) that it was a case of jumping before being pushed.
On March 7, 2019, TEI Biosciences, Inc. ("TEI"), one of our wholly-owned subsidiaries , received a Warning Letter (the “Warning Letter”
, dated March 6, 2019, from the FDA. The warning letter related to quality systems issues at TEI's manufacturing facility located in Boston, Massachusetts. The letter resulted from an inspection held at that facility in October and November 2018 and did not identify any new observations that were not already provided in the Form 483 that followed the inspection. We submitted our initial response to the FDA Warning Letter on March 28, 2019 andprovide regular progress reports to the FDA as to its corrective actions and, since the conclusion of the inspection, we have undertaken significant efforts to remediate the observations and continue to do so. On October 28, 2021 the FDA initiated an inspection of the facility and at the conclusion of the inspection issued a FDA Form 483 on November 12, 2021 (the "2021 Form 483"). We provided an initial response to the inspection observations and will continue to provide responses to the FDA. On March 1, 2023, the FDA commenced an inspection of the facility, and we anticipate that the FDA will issue an FDA Form 483 at the conclusion of this inspection. The Warning Letter and the 2021 FDA Form 483 do not restrict our ability to manufacture or ship products or require the recall of any products, nor do they restrict our ability to seek FDA 510(k) clearance of products. Additionally, premarket approval applications for Class III devices to which the Quality System regulation violations are reasonably related will not be approved until the violations have been corrected. The TEI Boston facility manufactures extracellular bovine matrix products. We cannot give any assurances that the FDA will be satisfied with our response to the Warning Letter or as to the expected date of the resolution of the matters included in the letter. Until the issues cited in the letter are resolved to the FDA’s satisfaction, the FDA may initiate additional regulatory action without further notice. Any adverse regulatory action, depending on its magnitude, may restrict us from effectively manufacturing, marketing and selling our products and could have a material adverse effect on our business, financial condition and results of operations.Revenues of products manufactured in the TEI Boston facility for the three months ended March 31, 2023 were approximately 4.4% of consolidated revenues.I don’t believe that this will impact supply of Integra’s dermal template but agree that Integra may suffer some reputational damage.
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