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Regulatory Focus™ > News Articles > 3 > FDA Flags Spate of Violations at French, Korean Manufacturers, Urges US Firm to Cease Distribution

FDA Flags Spate of Violations at French, Korean Manufacturers, Urges US Firm to Cease Distribution

Posted 13 March 2018 | By Ana Mulero 

FDA Flags Spate of Violations at French, Korean Manufacturers, Urges US Firm to Cease Distribution

Investigators from US Food and Drug Administration (FDA) who inspected a French drug contact testing laboratory and a medical device manufacturer in the Republic of Korea revealed several GMP violations.

In separate warning letters issued over inadequacy in responding to previous inspectional observations, the agency noted a lack of corrective actions to address manufacturing issues – ranging from invalidated testing processes to a breach of a quality agreement over the customer’s approval for changes made to test methods – at Méru, France-based Quality Controle & Quale-Controle-C.E. Bac, as well as inadequate procedures for CAPAs and device design changes, among others, at Seoul-based Dexcowin. 

The French firm’s October 2017 response failed to address retrospective reviews of test results, and it did not include required scientific justifications for an assigned root cause, which “stated that dirty glassware used in all prior preparations and tests” caused failures in testing methods, according to FDA.

Meanwhile, both of Dexcowin’s September and October response letters were also deemed inadequate due to a lack of retrospective reviews – required for the cited CAPA procedures and all design changes. Other violations cited at the manufacturer of portable dental diagnostic X-ray devices include a failure to validate computer software, no justification “behind the identical ratings and evaluation of each supplier, and undocumented personnel training requirements and procedures.

There were no established procedures for adverse event reporting to FDA at the time of the inspection at Dexcom’s facility either, FDA said. The firm “did not submit reports of accidental radiation occurrence, despite acknowledging that the patients most likely received accidental radiation exposure” for complaints involving X-Rays that were “not generated” or “not exposed.”


Yet another warning letter was issued to Chicago-based Opternative after the agency learned the firm has been marketing its On-Line Opternative Eye Examination Mobile Medical App device in the US without the required marketing clearance or approval. The firm was made aware of the need for a premarket submission to FDA during a June 2016 meeting, according to FDA.

“Our office requests that Opternative, Inc. immediately cease activities that results in the misbranding or adulteration” of the eye examination device, including the “commercial distribution of the device through your online website,” FDA said.

Quality Controle & Quale-Controle-C.E. Bac



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