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855641

Wedgewood Connect, LLC — FEI 3003434972

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
November 5, 2013
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
116221 CFR 211.28(a)Protective Apparel Not Worn
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
143521 CFR 211.42(c)(10)(v)Cleaning System
143621 CFR 211.42(c)(10)(vi)Equipment to control conditions
145121 CFR 211.113(b)Procedures for sterile drug products
145221 CFR 211.113(b)Validation lacking for sterile drug products
193221 CFR 211.167(a)Sterility/pyrogen-free testing
202621 CFR 211.192Quality control unit review of records
202721 CFR 211.192Investigations of discrepancies, failures
220121 CFR 211.186(b)(5)Calculated Excess of Components Used
356221 CFR 211.56(c)Written procedures lacking for use of pesticides etc.
358521 CFR 211.110(a)Control procedures to monitor and validate performance
361421 CFR 211.160(b)(4)Written calibration procedures
441821 CFR 211.42(b)Adequate space lacking to prevent mix-ups and contamination