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

Source: https://www.globalkeysolutions.net/records/483/quest-diagnostics-nichols-institute/828abfef-6f15-4c98-932c-fc33b815c674

> FDA 483 for Quest Diagnostics Nichols Institute on September 23, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Quest Diagnostics Nichols Institute
- Inspection Date: 2019-09-23
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: 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.

## Related Documents

- [483 - 2021-08-30](https://www.globalkeysolutions.net/records/483/quest-diagnostics-nichols-institute/86e6203b-3c90-4948-92c3-045942709c02)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/shavon-l-square/6a15df34-1af6-44f7-8874-c8606691f7e0)
- [Amanda B. Athey](https://www.globalkeysolutions.net/people/amanda-b-athey/6f681ae5-ccab-4a97-89ac-29d9fc53dbdb)

Company: https://www.globalkeysolutions.net/companies/quest-diagnostics-nichols-institute/76fdabb3-2e73-453c-9461-9d20b2c531ee

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e