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1259242

Scapa Tapes North America LLC — FEI 3015200795

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 23, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Knoxville, TN (United States)

Facility

Other inspections at this facility

  • 1173193 (VAI Fri Jun 17 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1117120 (VAI Fri Feb 07 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1028522 (NAI Wed Oct 04 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1028544 (NAI Wed Oct 04 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1028558 (NAI Wed Oct 04 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
180921 CFR 211.160(a)Following/documenting laboratory controls
357021 CFR 211.100(a)Approval and review of procedures
358321 CFR 211.110(a)Written in-process control procedures