FDA 483 - Geneva Laboratories, Inc - November 04, 2025

Geneva Laboratories, Inc. in Elkhorn, WI, a contract testing laboratory, was cited for three observations during an FDA inspection. The firm failed to follow quality control unit procedures for out-of-specification results and resampling, used inadequately designed and qualified stability chambers with numerous environmental excursions, and lacked appropriate computer controls to prevent unauthorized editing of raw electronic data. These issues indicate significant deficiencies in quality system management and data integrity.