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1275280

Wedgewood Connect, LLC — FEI 3003434972

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 3, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
San Jose, CA (United States)

Facility

Other inspections at this facility

  • 1224880 (VAI Fri Nov 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1158151 (VAI Fri Dec 03 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1076909 (VAI Wed Dec 19 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1014307 (VAI Thu Jun 15 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 902151 (OAI Tue Oct 07 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
136121 CFR 211.100(a)Absence of Written Procedures
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
145121 CFR 211.113(b)Procedures for sterile drug products
192221 CFR 211.166(a)(4)Testing in same container - closure system