EQS-Adhoc: Internal investigation by Vita 34 AG reveals irregularities related to a limited number of biological samples at one of its subsidiaries regarding compliance with medical law requirements

Internal investigation by Vita 34 AG reveals irregularities related to a limited number of biological samples at one of its subsidiaries regarding compliance with medical law requirements

Leipzig, 10 November 2023 - Based on an internal notice, Vita 34 AG has conducted an investigation at one of its small subsidiaries. This revealed potential irregularities in a total of not more than 1,700 umbilical cord blood samples regarding compliance with medical law requirements, which could lead to these samples being not acceptable for medical treatment or requiring an additional permit for use. The number of affected samples corresponds to approximately 0.2 percent of all biological samples stored by Vita Group. Customer samples at Vita 34 AG and all other subsidiaries are not impacted.

The possible irregularities identified relate to the required qualifications of a responsible medical person and formal inaccuracies in the documentation of some of the samples, which could have an impact on the subsidiary’s manufacturing authorization. However, the Management Board of Vita 34 believes that the biological quality of the samples is not affected by these regulatory issues.

Whether there is a financial impact and the exact extent of a possible financial impact cannot be assessed conclusively at this time. Should the risks described above fully materialize, Vita 34 estimates a possible financial burden for the subsidiary of low single digit million euros in the coming years.

Vita 34 will work closely and transparently with the responsible authorities to clarify the facts.

Person required to report: Jakub Baran (Chief Executive Officer)

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