FDA EIR - DCI Donor Services - June 25, 2021

An FDA "for cause" inspection of DCI Donor Services, located in Albuquerque, NM, was conducted from June 21 to June 25, 2021. This inspection, initiated due to a notification concerning tissue recovery, adhered to Compliance Program 7341.002 for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), incorporating COVID-19 guidelines. The scope included donor screening, testing, recovery, tissue quarantine, facilities, sanitation, quality control, deviations, and environmental testing.

A key observation, discussed during the closeout meeting, highlighted the company's failure to follow its own Standard Operating Procedure (SOP) regarding environmental monitoring. Specifically, environmental swab results from February 2019 showed a high colony-forming unit count in a controlled area that required the initiation of a non-conformance, which was not done. Management acknowledged this procedural lapse and committed to adhering to the firm's SOP in the future.

Despite this identified internal procedural issue, the inspection concluded without significant deficiencies, and no Form FDA 483 (Inspectional Observations) was issued, indicating that formal regulatory actions were not deemed necessary at the time.