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870667

Wedgewood Connect, LLC — FEI 3003434972

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
March 6, 2014
Fiscal Year
2014
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
135821 CFR 211.100(b)SOPs not followed / documented
139521 CFR 211.103Actual vs. theoretical yields not determined
145221 CFR 211.113(b)Validation lacking for sterile drug products
185121 CFR 211.84(e)Rejecting When Specifications Not Met
188321 CFR 211.165(a)Testing and release for distribution
188521 CFR 211.165(b)Microbiological testing
191421 CFR 211.166(a)Lack of written stability program
220521 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
435921 CFR 211.170(b)(1)Retention time of reserve samples, in general