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991448

Nomax, Inc. — FEI 1937310

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 27, 2016
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Saint Louis, MO (United States)

Facility

Other inspections at this facility

  • 1229313 (NAI Fri Feb 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1194330 (VAI Fri Dec 02 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1180777 (NAI Fri Jun 24 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1042641 (VAI Thu Feb 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 895449 (VAI Wed Sep 17 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
1471221 CFR 820.184DHR - not or inadequately maintained
312721 CFR 820.80(e)Documentation
312821 CFR 820.90(a)Nonconforming product control
317221 CFR 820.198(c)Investigation of device failures
342521 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
366821 CFR 820.20(c)Management review dates
369621 CFR 820.100(b)Documentation