Cardinal Health dba Specialty Pharmaceutical Services – FDA EIR, Oct 5, 2016

An FDA establishment inspection was conducted at Cardinal Health dba Specialty Pharmaceutical in La Vergne, TN, on October 5, 2016. This was the initial inspection for the facility's Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) operations, where it is registered as a storage and distribution location. The inspection, performed under current good tissue practices, found no deficiencies, and consequently, no FDA Form 483, Inspectional Observations, was issued. The facility had not yet begun storing or distributing HCT/P products at the time of the inspection, but plans, storage locations, and operational procedures were available for review. The firm's recall procedures, inventory, tracking, and temperature monitoring logs were reviewed and found compliant. No samples were collected, and no refusals were encountered. Management was reminded of their responsibility to comply with applicable regulatory acts, including the Federal Food, Drug, and Cosmetic Act and/or the Public Health Service Act, and the implications of non-adherence. This inspection concluded without any required corrective actions due to the absence of observed violations.