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Medical Devices / Inspections and Audits

FDA Scolds Sound Ergonomics for Missing Procedures

Jan. 10, 2019

The FDA cited Sound Ergonomics, a Washington specification developer, for failing to develop or establish procedures used for medical device reporting and complaint handling.

During a July 31 to Aug. 6, 2018 inspection, the investigator found that the facility hadn’t developed written procedures for medical device reporting to the FDA.

The operations manager also said that the facility had no defined, documented or implemented procedures to handle customer complaints, according to the Form 483.

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