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1102830

Quest Diagnostics Nichols Institute — FEI 3005010397

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
September 23, 2019
Fiscal Year
2019
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Chantilly, VA (United States)

Facility

Other inspections at this facility

  • 1270643 (NAI Thu May 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1150115 (VAI Mon Aug 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 998528 (NAI Thu Jan 12 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 919955 (NAI Thu Mar 26 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 835530 (NAI Wed Jun 19 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1228821 CFR 1271.80(c)Manufacturer instructions not followed
1231121 CFR 1271.160(b)(1)Ensuring appropriate core requirements followed