FDA 483 - Tianjin Medis Medical Device Co., LTD. - November 16, 2023

During a U.S. Food and Drug Administration (FDA) inspection conducted from November 13-16, 2023, Tianjin Medis Medical Device Co., LTD., a medical device manufacturer, received a Form FDA 483 detailing significant observations. The inspection highlighted two primary areas of concern regarding the company's quality management system and documentation practices.

First, the firm's records for the effectiveness checks of several Corrective and Preventive Actions (CAPAs), including 2021-2 and 2021-8, were deemed inadequate. This indicated a lack of sufficient documentation to verify that the implemented corrective measures successfully resolved the identified issues. Second, the Design History File (DHF) for the "AccuCuff" medical device, which is distributed in the U.S. market, was incomplete. It lacked or did not properly reference essential labels, labeling information, and product testing data pertinent to devices marketed in the United States.

These observations, issued under the Federal Food, Drug and Cosmetic Act, suggest potential non-compliance with established medical device regulations. Tianjin Medis Medical Device Co., LTD. is now expected to promptly address these deficiencies by implementing and documenting comprehensive corrective actions to ensure full adherence to FDA requirements. The company has indicated a commitment to rectify the identified issues.