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902151

Wedgewood Connect, LLC — FEI 3003434972

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
October 7, 2014
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
San Jose, CA (United States)

Facility

Other inspections at this facility

  • 1275280 (VAI Thu Jul 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 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))

Recent compliance actions

Citations

IDCFRDescription
109821 CFR 211.22(c)Approve or reject procedures or specs
145121 CFR 211.113(b)Procedures for sterile drug products
145421 CFR 211.115(a)Reprocessing procedures not written or followed
202721 CFR 211.192Investigations of discrepancies, failures