FDA 483 - Quest Diagnostics Nichols Institute - September 23, 2019
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 828abfef-6f15-4c98-932c-fc33b815c674