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1093708

Sciegen Pharmaceuticals Inc — FEI 3008298016

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 21, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Hauppauge, NY (United States)

Facility

Other inspections at this facility

  • 1297968 (NAI Fri Dec 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1229682 (NAI Tue Feb 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1204858 (OAI Fri Apr 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1178870 (VAI Fri Sep 02 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1159297 (VAI Mon Dec 20 2021 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
136121 CFR 211.100(a)Absence of Written Procedures
202721 CFR 211.192Investigations of discrepancies, failures
440121 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.