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1101454

Forma Life Sciences, Inc — FEI 3004492248

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 6, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Irvine, CA (United States)

Facility

Other inspections at this facility

  • 1230058 (VAI Fri Feb 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1110675 (NAI Wed Oct 30 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
240221 CFR 211.194(a)(5)Testing Calculations
360321 CFR 211.160(b)Scientifically sound laboratory controls
891121 CFR 314.81(b)(1)(ii)Failure to meet specifications