FDA 483 - Fagron Analytical Services - March 26, 2026

Fagron Analytical Services, LLC, a contract laboratory in Wichita, KS, was cited for data integrity issues during an FDA inspection. The inspection revealed a lack of data backup for a Mettler Toledo pH meter and the use of a shared login, preventing proper attribution of test results. These deficiencies raise concerns about the completeness, accuracy, and traceability of critical pH test data.