FDA 483 - Ark Pharmacy, PC (dba Regency Medical Pharmacy) - February 24, 2022

Ark Pharmacy, PC (dba Regency Medical Pharmacy) in Newbury Park, CA, was inspected by the FDA from February 17-24, 2022. The inspection identified a significant quality control issue involving the use of non-pharmaceutical grade components in drug product formulation. Specifically, Arrowhead® distilled water was used in the compounding of non-sterile drug products.