FDA 483 - Quest Diagnostics Nichols Institute - August 30, 2021

An FDA inspection of Quest Diagnostics Nichols Institute's Donor Testing Laboratory in Chantilly, VA, revealed two significant observations. The firm failed to report repeatedly reactive communicable disease test results according to manufacturer instructions and did not retain critical test result records for the appropriate length of time. These issues indicate deficiencies in quality control and record-keeping practices for donor testing.