Conversio Health – FDA Warning Letter, Sep 25, 2019

On September 10, 2020, the FDA issued a Warning Letter to Integrated Health Concepts Inc. dba Conversio Health following an inspection from August 13 to September 25, 2019. The inspection revealed serious deficiencies in the production of sterile drug products, leading to adulterated products under section 501(a)(2)(A) of the FDCA.

Key violations included: - ISO 5 and ISO 7 areas having vents opening to non-classified areas. - Failure to perform adequate smoke studies under dynamic conditions in the ISO 5 area. - Unsealed ceiling surfaces in ISO 5 and ISO 7 areas. - Media fills not performed under challenging conditions. - Failure to depyrogenate glassware, utensils, or temporary containers. - Refilling non-sterile spray bottles for use in the ISO 5 area. - Use of non-sterile wipes on ISO 5 surfaces. - Operator blocking first pass air during aseptic processing. - Failure to disinfect materials and components before entering the ISO 5 area.

The firm initiated a recall of all sterile drug products on November 12, 2019, and ceased sterile operations, resuming on February 10, 2020. While some corrective actions were acknowledged, others were deemed deficient, such as inadequate smoke study recordings and an unsubmitted revised media fill procedure. The FDA strongly recommended