FDA 483 - Donor Services Laboratory, Inc. Las Vegas - April 12, 2024

An FDA inspection of Donor Services Laboratory, Inc. Las Vegas, a RCDAD Testing Laboratory, revealed significant issues across its operations. The firm failed to adhere to manufacturer's instructions for communicable disease testing, did not adequately verify computer software performance, and used unvalidated testing equipment. Additionally, deficiencies were noted in record-keeping, the quality program's handling of deviations, and the maintenance of test kit lot documentation.