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Medical Devices / Inspections and Audits

FDA Cites French Devicemaker for MDRs

Oct. 23, 2018

Cair LGL, a manufacturer of medical devices and equipment for hospitals, failed to properly submit MDRs, adequately maintain complaint files or evaluate complaints, the FDA said following a February inspection of its facility in Lissieu, France.

The FDA issued a Form 483 noting the facility failed to submit an MDR report within the required 30-day window of receiving or becoming aware of information suggesting a device had malfunctioned in a way that would likely contribute to death or serious injury if it recurred.

The inspection found the firm missed the 30-day reporting deadline by up to 212 days.

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