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1102216

Greer Laboratories, Inc. — FEI 1011574

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 11, 2019
Fiscal Year
2019
Product Type
Biologics
Project Area
Vaccines and Allergenic Products
Location
Lenoir, NC (United States)

Facility

Other inspections at this facility

  • 1256993 (VAI Wed Dec 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1182373 (VAI Tue Nov 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1036168 (VAI Wed Nov 22 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1014272 (VAI Thu Jun 15 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 947983 (VAI Thu Aug 27 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
142121 CFR 211.42(c)(10)Aseptic Processing Area
1597321 CFR 111.120(c)Quality control operations - material review, disposition decision
359421 CFR 211.110(d)Rejected in-process materials not quarantined
601121 CFR 123.8(a)(3)(ii)Corrective action record review adequacy