FDA 483 - Quest Diagnostics Nichols Institute - September 23, 2019

Quest Diagnostics Nichols Institute, a donor testing laboratory in Chantilly, VA, was inspected by the FDA from September 9-23, 2019. The inspection revealed that the firm failed to perform communicable disease agent testing, specifically HIV-1/HCV/HBV NAT testing, in accordance with manufacturer instructions. Additionally, the firm's quality program did not ensure that appropriate procedures were maintained, followed, and reviewed, leading to improper handling and reporting of non-discriminated specimens.