FDA EIR - NINGBO TIANYI MEDICAL APPLIANCE CO., LTD. - August 24, 2017

An FDA inspection of Ningbo Tianyi Medical Appliance Co. Ltd. occurred from August 21 to August 24, 2017. Operating under the FDA's regulatory framework for medical device quality systems, the inspection identified several issues, although no FDA Form 483, Inspectional Observations, was issued. Main violations included the use of an unvalidated electronic spreadsheet for quality control testing records, with original data being discarded. This was addressed during the inspection, with the firm returning to manual record-keeping and committing to a permanent, validated solution. Another concern was the absence of a procedure for conducting on-site audits for trading companies acting as suppliers. Additionally, the firm lacked a system for tracking manufacturing scrap, which can reveal process variations, and its nonconformance procedure did not explicitly require investigations for all nonconformances. During the close-out meeting, company management committed to correcting these deficiencies, including revising relevant procedures and implementing new tracking systems.