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FDA Issues Warning Letter to Swedish IVD Firm

NEW YORK (360Dx) – The US Food and Drug Administration has issued a warning letter to Swedish in vitro diagnostics device firm Euro Diagnostica, citing at least five violations, as well as inadequate responses from the company to the agency's concerns.  

The warning letter, dated Sept. 20, was posted on the FDA's website this week. It noted violations that the agency observed during an inspection of Euro Diagnostica's facility in Malmo, Sweden in January. Generally, inspectors found that devices manufactured by Euro Diagnostica were adulterated as they did not conform to current good manufacturing practice requirements.

More specifically, the violations included a failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit; failure to document all corrective and preventive action activities and their results; failure to create and maintain procedures to ensure that formal document reviews of design results are planned and conducted at appropriate stages of the product's design development; failure to create and maintain procedures for verifying a product's design, confirm that the design output meets the design input requirements, and document in the design history file the results of the design verification; and failure to create procedures for quality audits and to conduct such audits in a manner that assures the quality system complies with the established quality system requirements and to determine the effectiveness of the quality system.

The letter noted that the violations cited in the warning letter may not include all violations that were found during the inspection.

In February and March, Euro Diagnostica CEO Elsa Beth Trautner responded to the FDA's concerns, but the FDA deemed her responses unsatisfactory. In some instances, while the firm provided corrective preventive action plans to address the violations, it did not provide evidence that the firm followed all the necessary steps as outlined by the plans, the agency said.

The agency said that it received further responses from Euro Diagnostica in June and August addressing the violations, and this week's warning letter does not pertain to those responses. They, along with other written material replying to the violations, will be evaluated, the FDA said.

Euro Diagnostica provides tools for the diagnosis, prognosis, monitoring, and treatment of inflammatory and related illnesses, according to the firm's website. It also develops assays for use in drug development.