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1268261

Soaptronic LLC — FEI 2027600

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 28, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Lake Forest, CA (United States)

Facility

Other inspections at this facility

  • 1118056 (VAI Fri Feb 14 2020 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
126321 CFR 211.68(b)Computer control of master formula records
136121 CFR 211.100(a)Absence of Written Procedures
139521 CFR 211.103Actual vs. theoretical yields not determined
150421 CFR 211.122(d)Labels and labeling stored separately
184421 CFR 211.84(d)(2)Establish reliability of supplier's C of A
194221 CFR 211.180(e)Records reviewed annually
202721 CFR 211.192Investigations of discrepancies, failures
240121 CFR 211.194(a)(4)Complete Test Data
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action