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1013173

Helget Gas Products, Inc. — FEI 1000138346

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 7, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Omaha, NE (United States)

Facility

Other inspections at this facility

  • 1259742 (NAI Tue Jul 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 923302 (NAI Wed Apr 22 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 759512 (NAI Mon Dec 12 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 696464 (NAI Thu Nov 04 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 616341 (NAI Thu Oct 01 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
135821 CFR 211.100(b)SOPs not followed / documented
203321 CFR 211.194(c)Testing and standardization of standards et. al.
441821 CFR 211.42(b)Adequate space lacking to prevent mix-ups and contamination