FDA 483 - Hiers Enterprises, LLC dba Northwest Compounding Pharmacy - November 10, 2021

An FDA inspection of Hiers Enterprises, LLC dba Northwest Compounding Pharmacy in Roseburg, OR, revealed significant deficiencies in the production of non-sterile drug products. Observations included inadequate containment and cleaning practices for hazardous and beta-lactam drugs, leading to potential cross-contamination. Additionally, personnel failed to change gloves frequently enough, further compromising product integrity.