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1230058

Forma Life Sciences, Inc — FEI 3004492248

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 23, 2024
Fiscal Year
2024
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Irvine, CA (United States)

Facility

Other inspections at this facility

  • 1110675 (NAI Wed Oct 30 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1101454 (VAI Fri Sep 06 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1005499 (VAI Fri Mar 03 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 860024 (VAI Fri Dec 20 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 785908 (NAI Wed May 23 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
117721 CFR 211.63Equipment Design, Size and Location
136121 CFR 211.100(a)Absence of Written Procedures
188321 CFR 211.165(a)Testing and release for distribution
194221 CFR 211.180(e)Records reviewed annually
202721 CFR 211.192Investigations of discrepancies, failures
360321 CFR 211.160(b)Scientifically sound laboratory controls
361621 CFR 211.165(d)Acceptance criteria for sampling & testing