FDA 483 - Tower Pharmacy and Compounding - September 19, 2019

Tower Pharmacy and Compounding in Mission Viejo, CA, received an FDA Form 483 for significant deficiencies observed during an inspection. The firm was cited for inadequate containment, segregation, and cleaning practices for highly potent drugs, leading to potential cross-contamination. Additionally, the pharmacy routinely used non-pharmaceutical grade components in the formulation of various compounded drug products.