FDA 483 - Medical Solutions International, Inc. - April 15, 2024

During an inspection from April 11-15, 2024, the U.S. Food and Drug Administration (FDA) issued a Form FDA-483 to Medical Solutions International, Inc., a medical device manufacturer. The inspection revealed four significant observations regarding the company's quality system and design controls, many of which were repeat findings from a prior inspection.Primary issues included inadequacies in procedures for design validation, design verification, and design change. Specifically, design validation procedures lacked provisions for ensuring devices meet user needs and intended uses, and validation records for the Class II Bipro Model SDS-CB200 lacked supporting data. The risk analysis for this device was incomplete, missing quantitative evaluation of risk and failure modes. Design verification procedures did not adequately ensure design outputs met design input requirements. Most notably, two design changes for the Bipro Model SDS-CB200 were implemented without proper documentation, validation, review, or approval as required by the company's own internal procedures. These observations indicate a failure to fully comply with established regulatory requirements for medical device quality systems. Medical Solutions International, Inc. has committed to correcting all identified deficiencies.