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816466

EarthLab Holdings Inc — FEI 3001237894

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 21, 2013
Fiscal Year
2013
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Creswell, OR (United States)

Facility

Other inspections at this facility

  • 1234051 (VAI Mon Apr 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1203387 (VAI Mon Apr 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1167397 (OAI Thu Apr 14 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1108568 (NAI Mon Aug 26 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 989601 (VAI Fri Sep 30 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
117721 CFR 211.63Equipment Design, Size and Location
150521 CFR 211.122(d)Label storage access limited to authorized personnel
155021 CFR 211.125(f)Procedures Written and Followed
181021 CFR 211.160(a)Lab controls established, including changes
185121 CFR 211.84(e)Rejecting When Specifications Not Met
188321 CFR 211.165(a)Testing and release for distribution
189121 CFR 211.165(f)Failing drug products not rejected
202621 CFR 211.192Quality control unit review of records
202721 CFR 211.192Investigations of discrepancies, failures
357321 CFR 211.101(b)Measured components for manufacturing
358321 CFR 211.110(a)Written in-process control procedures
359121 CFR 211.110(b)In-process materials specifications
360321 CFR 211.160(b)Scientifically sound laboratory controls
361621 CFR 211.165(d)Acceptance criteria for sampling & testing
433821 CFR 211.150(b)Recall facilitation
434421 CFR 211.160(b)(1)Sampling and testing procedures described
435021 CFR 211.160(b)(3)Drug products-sampling procedures/specifications
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
435421 CFR 211.165(d)Acceptance/Rejection Levels