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1251557

ThermoFisher Scientific dba Patheon Softgels Inc. — FEI 3001451366

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 17, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
High Point, NC (United States)

Facility

Other inspections at this facility

  • 1080798 (NAI Wed Jan 30 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1023652 (NAI Fri Aug 11 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 912784 (NAI Thu Jan 29 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 852044 (NAI Wed Sep 18 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 801960 (NAI Wed Sep 26 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121521 CFR 211.67(b)Written procedures not established/followed
201221 CFR 211.188(b)Batch production and Batch Control Record Requirements