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Quest Diagnostics Nichols Institute

FDA Regulatory Profile

Quest Diagnostics Nichols Institute has 0 FDA recalls, 10 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
May 15, 2025 · NAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections10Nov 11, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
May 15, 2025Chantilly, VABiologicsNo Action Indicated (NAI)3005010397
May 1, 2025San Juan Capistrano, CADevicesNo Action Indicated (NAI)3007521501
Apr 4, 2025San Juan Capistrano, CADevicesNo Action Indicated (NAI)3007521501
Aug 30, 2021Chantilly, VABiologicsNo Action Indicated (NAI)3005010397
Sep 23, 2019Chantilly, VABiologicsVoluntary Action Indicated (VAI)3005010397
Jan 12, 2017Chantilly, VABiologicsNo Action Indicated (NAI)3005010397
Mar 26, 2015Chantilly, VABiologicsNo Action Indicated (NAI)3005010397
Jun 19, 2013Chantilly, VABiologicsVoluntary Action Indicated (VAI)3005010397
Aug 10, 2011Chantilly, VABiologicsNo Action Indicated (NAI)3005010397
Jun 17, 2010Chantilly, VABiologicsNo Action Indicated (NAI)3005010397

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3005010397Chantilly, VA8May 15, 2025
FEI 3007521501San Juan Capistrano, CA2May 1, 2025

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.