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

Source: https://www.globalkeysolutions.net/records/483/quest-diagnostics-nichols-institute/86e6203b-3c90-4948-92c3-045942709c02

> FDA 483 for Quest Diagnostics Nichols Institute on August 30, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Quest Diagnostics Nichols Institute
- Inspection Date: 2021-08-30
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: 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.

## Related Documents

- [483 - 2019-09-23](https://www.globalkeysolutions.net/records/483/quest-diagnostics-nichols-institute/828abfef-6f15-4c98-932c-fc33b815c674)

## Related Officers

- [La-tasha M. Gunter](https://www.globalkeysolutions.net/people/la-tasha-m-gunter/db9cd9cf-db0a-4c31-9f7c-24760750f34d)

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