FDA EIR - UPS Supply Chain Solutions Inc., - August 15, 2019

An FDA inspection of UPS Supply Chain Solutions Inc. in Louisville, KY, was conducted from August 12 to August 15, 2019. This initial inspection focused on the company's role as a tissue distributor, specifically regarding Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), under the FY 20 Biologics Workplan and Compliance Program 7341.002. The inspection included a review of standard operating procedures, a detailed walk-through of the warehouse facility, and an examination of processes for tissue receipt, storage, and distribution. Investigators confirmed that products are segregated by customer, and temperature records for storage were maintained within acceptable parameters. Notably, the inspection concluded without any adverse findings or observations. Therefore, no violations were cited, and no FDA Form 483, "Inspectional Observations," was issued to the company. As a result, there are no specific required actions for UPS Supply Chain Solutions Inc. stemming from this inspection, indicating compliance with regulatory expectations for its operations.