Home / Inspections / 730338

730338

Helget Gas Products, Inc. — FEI 3003406963

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 3, 2011
Fiscal Year
2011
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Bensenville, IL (United States)

Facility

Other inspections at this facility

  • 1277523 (VAI Tue Aug 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1216407 (NAI Wed Aug 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1022756 (NAI Thu Aug 03 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 976748 (NAI Thu Jul 07 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 891969 (VAI Tue Aug 26 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
136121 CFR 211.100(a)Absence of Written Procedures
200921 CFR 211.188Prepared for each batch, include complete information
202721 CFR 211.192Investigations of discrepancies, failures
242721 CFR 110.80(b)(9)Proper disposal of adulterated product
256721 CFR 211.198(a)Adverse Drug Experience
361621 CFR 211.165(d)Acceptance criteria for sampling & testing
437221 CFR 211.188(b)(8)Labeling control records including specimens or copies