FDA 483 - Integrated Health Concepts Inc. - July 23, 2021

An FDA inspection of Integrated Health Concepts Inc. in San Luis Obispo, CA, a producer of sterile drugs, identified two observations related to aseptic processing. The firm was cited for personnel failing to sanitize gloves after touching non-aseptic surfaces before handling materials in an ISO 5 area, and for blocking critical airflow within a Biological Safety Cabinet during sterile drug compounding.