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960084

Wickham Micro Limited — FEI 3009798720

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 17, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Gosport (United Kingdom)

Facility

Other inspections at this facility

  • 1276464 (VAI Thu Feb 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1109744 (NAI Wed Sep 25 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1120170 (VAI Thu Jun 27 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1062304 (VAI Thu Jul 27 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 726398 (VAI Thu Mar 03 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
122021 CFR 211.67(b)(3)Cleaning SOPs/instructions
122721 CFR 211.67(c)Cleaning/maintenance records not kept
360321 CFR 211.160(b)Scientifically sound laboratory controls
430321 CFR 211.67(b)Written procedures fail to include