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1155063

Regeneron Pharmaceuticals Inc — FEI 1000514603

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 25, 2021
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Rensselaer, NY (United States)

Facility

Other inspections at this facility

  • 1230565 (VAI Fri Mar 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1106821 (VAI Fri Oct 18 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1030807 (NAI Thu Oct 05 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 983604 (VAI Fri Aug 19 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 883187 (VAI Fri Jun 13 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
143521 CFR 211.42(c)(10)(v)Cleaning System
145121 CFR 211.113(b)Procedures for sterile drug products
145221 CFR 211.113(b)Validation lacking for sterile drug products
202721 CFR 211.192Investigations of discrepancies, failures
457621 CFR 211.192No written record of investigation
908921 CFR 600.14(c)When to report