FDAnews Device Daily Bulletin
Medical Devices / Inspections and Audits

Suzhou Medical Hit for Complaint Handling Deficiencies

Aug. 30, 2018

The FDA hit medical device manufacturer Suzhou Medical with a Form 483 over its complaint handling practices.

The firm did not adequately manage its complaint files. Specifically, its procedure to report complaints to the quality department for various activities — such as investigation and determination of reportability — was not followed fully, as it did not document all activities.

Additionally, the facility’s complaint records did not include or refer to the location of supporting documentation for complaint investigations or evaluations.

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