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682008

PhytogenX, Inc. — FEI 3006892202

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 30, 2010
Fiscal Year
2010
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Morgantown, PA (United States)

Facility

Other inspections at this facility

  • 1265048 (VAI Thu Mar 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1208087 (NAI Tue Jun 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1117358 (VAI Mon Feb 10 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1079308 (VAI Thu Feb 14 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 935526 (VAI Fri Jul 31 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
121521 CFR 211.67(b)Written procedures not established/followed
136121 CFR 211.100(a)Absence of Written Procedures
145021 CFR 211.113(a)Procedures for non-sterile drug products
203121 CFR 211.194(a)Complete test data included in records