FDAnews Device Daily Bulletin
Medical Devices / Inspections and Audits

Chinese Devicemaker Hit for Complaint Handling

Jan. 3, 2019

The FDA cited Tianjin, China device manufacturer Tianjin New Bay Bioresearch, calling the firm out for its complaint handling protocols.

Specifically, the facility didn’t have provisions in place that allowed it to evaluate the adverse event reportability of complaints it received from customers.

The firm’s individual complaint records failed to include evaluations of each complaint to determine their adverse event reportability.

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