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1224880

Wedgewood Connect, LLC — FEI 3003434972

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 17, 2023
Fiscal Year
2024
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))
  • 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
104921 CFR 211.22(a)Approve or reject components, products
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
119421 CFR 211.42(c)Defined areas of adequate size for operations
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
143521 CFR 211.42(c)(10)(v)Cleaning System
145121 CFR 211.113(b)Procedures for sterile drug products
22787FDCA 503B(a)(10)(A)Drug product labels, fails to include
457621 CFR 211.192No written record of investigation