FDA EIR - Cardinal Health dba Specialty Pharmaceutical Services - April 12, 2011

An FDA inspection of Cardinal Health dba Specialty Pharmaceutical Services (SPS) in La Vergne, TN, was conducted from April 6 to April 12, 2011. This high-priority inspection was initiated under regulatory framework C.P. 7352.002, concerning unapproved new drugs (marketed, human, prescription drugs only). The primary focus was to assess the firm's practices regarding the receipt, disposition, and distribution of pharmaceutical and medical device finished products, particularly in response to a previous investigation revealing the potential distribution of unapproved drugs.

During this inspection, coverage specifically verified the destruction of unapproved drug products and reviewed the inventory status of other pharmaceutical products. The firm provided extensive documentation related to product destruction, including waste manifests and certificates of incineration, confirming that unapproved products were being appropriately disposed of. Inventory records indicated that certain products were on hold pending distribution or return status, with no shipments of specified unapproved products having occurred since early 2011.

Notably, no objectionable conditions or discrepancies were identified during this inspection, and consequently, an FDA Form 483 was not issued to Cardinal Health dba SPS. The firm cooperated fully, providing all requested documentation, though an affidavit presented by investigators was not signed due to corporate policy. As no violations were observed, no specific corrective actions were required as a direct outcome of this inspection, affirming the firm's compliance with the regulatory focus of the assignment.