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949108

Blaine Labs Inc — FEI 3001744192

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 16, 2015
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Santa Fe Springs, CA (United States)

Facility

Other inspections at this facility

  • 1226067 (OAI Fri Dec 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1149759 (OAI Tue Aug 24 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 975445 (VAI Thu Mar 24 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 832318 (VAI Fri Apr 26 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 792738 (VAI Mon Jul 23 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
117721 CFR 211.63Equipment Design, Size and Location
136121 CFR 211.100(a)Absence of Written Procedures
139521 CFR 211.103Actual vs. theoretical yields not determined
144821 CFR 211.111Establishment of time limitations
149521 CFR 211.122(a)Written procedures describing in detail
194321 CFR 211.180(e)(1)Review of representative number of batches
202721 CFR 211.192Investigations of discrepancies, failures
241921 CFR 211.198(a)Complaint Handling Procedure
363221 CFR 211.170(b)Annual visual exams of drug products
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action