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1279220

Lonza Tampa LLC — FEI 3001549109

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 22, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Tampa, FL (United States)

Facility

Other inspections at this facility

  • 1219089 (VAI Fri Sep 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1153431 (VAI Fri Oct 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1059866 (VAI Fri Jul 20 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1017944 (VAI Fri Jul 14 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 551193 (VAI Wed Dec 10 2008 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
121821 CFR 211.67(b)(1)Cleaning SOP/responsibility
122721 CFR 211.67(c)Cleaning/maintenance records not kept
126321 CFR 211.68(b)Computer control of master formula records
145021 CFR 211.113(a)Procedures for non-sterile drug products
354721 CFR 211.46(b)Equipment for Environmental Control
359221 CFR 211.110(c)In-process materials characteristics testing
360321 CFR 211.160(b)Scientifically sound laboratory controls