Texas Devicemaker Cited for MDR Failures

January 31, 2020

The FDA wrote up Wello, a device manufacturer in Addison, Texas in a Form 483 for failing to comply with medical device reporting (MDR) requirements.

The firm, which was inspected in December 2019, did not maintain or implement a written MDR procedure for handling, identifying and promptly transmitting them, the agency found.

The investigator also observed that the company never registered with the agency for an eSubmitter account, used to make certain electronic submissions, including MDRs.

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