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936886

Gemini Pharmaceuticals, Inc. — FEI 2432926

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 30, 2015
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Commack, NY (United States)

Facility

Other inspections at this facility

  • 1175407 (VAI Tue Jul 26 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1064447 (NAI Thu Aug 23 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1041525 (VAI Fri Feb 16 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 856101 (NAI Fri Nov 08 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 804876 (NAI Fri Sep 07 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
117721 CFR 211.63Equipment Design, Size and Location
360321 CFR 211.160(b)Scientifically sound laboratory controls
363221 CFR 211.170(b)Annual visual exams of drug products
436921 CFR 211.188(b)(11)Identification of persons involved, each significant step