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1118056

Soaptronic LLC — FEI 2027600

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 14, 2020
Fiscal Year
2020
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Lake Forest, CA (United States)

Facility

Other inspections at this facility

  • 1268261 (VAI Mon Apr 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 983015 (VAI Thu Jun 23 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 750388 (VAI Fri Oct 21 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 707105 (VAI Thu Dec 16 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 658968 (VAI Wed Apr 28 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
111121 CFR 211.25(a)Training , Education , Experience overall
113621 CFR 211.25(c)Inadequate number of personnel
126321 CFR 211.68(b)Computer control of master formula records
189121 CFR 211.165(f)Failing drug products not rejected
360321 CFR 211.160(b)Scientifically sound laboratory controls