FDA 483 - NINGBO TIANYI MEDICAL APPLIANCE CO., LTD. - July 25, 2013

NINGBO TIANYI MEDICAL APPLIANCE CO., LTD. in NINGBO, China, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to adequately establish procedures for process changes, specifically lacking documented justification for revalidation decisions. Additionally, procedures for the acceptance of in-process products were not established, leading to the use of out-of-specification components in finished medical devices.