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1276957

Nelson Laboratories, LLC — FEI 3000233845

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 30, 2025
Fiscal Year
2025
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Salt Lake City, UT (United States)

Facility

Other inspections at this facility

  • 1207358 (VAI Fri Jun 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1159993 (NAI Tue Nov 09 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1053690 (NAI Fri Mar 30 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1047037 (NAI Fri Feb 23 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 966359 (VAI Fri Apr 15 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1232221 CFR 1271.160(b)(4)Training of personnel
1232321 CFR 1271.160(b)(5)Monitoring systems
1233721 CFR 1271.180(a)Design adequate to bar spread of CD's
1235621 CFR 1271.195(a)Adequate control, proper conditions
1238721 CFR 1271.220(a)Causing contamination, increasing risks
1238921 CFR 1271.220(c)Specified requirements for in-process controls
1243721 CFR 1271.270(a)Records incomplete
240121 CFR 211.194(a)(4)Complete Test Data
327021 CFR 820.80(c)Documentation
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified
430721 CFR 211.80(d)Status of Each Lot Identified