FDA 483 - Integrated Health Concepts Inc. - September 25, 2019

The inspection of Integrated Health Concepts Inc. dba Conversio Health in San Luis Obispo, CA, a producer of sterile drugs, revealed significant deficiencies in aseptic processing and environmental controls. Observations included inadequate cleanroom design, insufficient sterilization methods, lack of environmental monitoring, and failures in media fill simulations, indicating a high risk of product contamination. These issues suggest a serious lack of control over sterile drug production.