FDA WARNING_LETTER - Visgeneer, Inc. - February 27, 2025

The FDA issued a warning letter to Dr. Ken-Shwo Dai of the firm located at No. 335 Zhong Hua Rd., Sec. 6, Xiangshan District, Hsinchu City, Taiwan, following an inspection conducted from February 24 to February 27, 2025. The inspection revealed significant violations concerning the manufacturing processes of the eBchek Blood Glucose Monitoring System and the eBuricacid/Uritouch Blood Uric Acid Monitoring System. These products are classified as medical devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act.

The primary issue identified was the failure to establish and maintain proper procedures for validating device design, as mandated by 21 CFR 820.30(g). Specifically, the firm lacked documentation for parts or software versions used in manufacturing, as well as production records for the units tested. The response from Dr. Dai, dated March 13, 2025, attempted to address these issues by referencing test reports and studies conducted on mass production units. However, the response was deemed inadequate due to missing information and inconsistencies in software version documentation.

The FDA highlighted discrepancies between the firm’s new analytical studies and the performance specifications cleared in the original 510(k) submission (k122181). These discrepancies included differences in precision and accuracy results, as well as the use of a different comparator method (YSI 2500 instead of YSI 2300) without justification.

The FDA requires the firm to provide a clear explanation and evidence of corrective actions taken to address these violations. This includes clarifying software version discrepancies, validating device performance with appropriate comparator methods, and ensuring all documentation is complete and accurate. Failure to adequately address these issues could result in further regulatory actions.