FDA 483 - Kappa Laboratories, Inc. - June 04, 2025

An FDA inspection of Kappa Laboratories, Inc., a contact microbiology and chemistry laboratory in Miami, revealed significant deficiencies in their quality control systems. The firm failed to adequately investigate out-of-specification results, lacked proper procedures for instrument calibration, and used uncalibrated equipment. These issues indicate a breakdown in laboratory controls and data integrity.