Globus Medical received warning letter from FDA over facility non-conformities.
On October 31, Globus Medical received a warning letter from the FDA resulting from an inspection of the facilities of Human Biologics of Texas, a subsidiary of Globus, located in San Antonio, Texas, in April 2018. The letter describes observed non-conformities to regulations for human cells, tissues, and cellular and tissue-based products relating to one allograft tissue product processed by Human Biologics of Texas and sold to end users by Globus Medical, Globus disclosed in a regulatory filing. The company said, "We take the matters identified in the warning letter seriously, are working diligently to address the FDA's observations, and intend to respond in the specified time period. We believe that the FDA's concerns set forth in the warning letter can be resolved without a material impact to our financial results. We cannot, however, give any assurances that the FDA will be satisfied with our response or as to the expected date of the resolution of the matters included in the warning letter. Until the issues cited in the warning letter are resolved to the FDA's satisfaction, additional legal or regulatory action may be taken without further notice. Any adverse action by the FDA, depending on its magnitude, may restrict us from effectively producing, marketing and selling the product that is the subject matter of the warning letter and could have a material adverse effect on our business, financial condition and results of operations."
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|Date:||Nov 13, 2018|
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