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FDA Inspection 1023304 — Fresenius USA Manufacturing, Inc.

Fresenius USA Manufacturing, Inc. — FEI 1713747

The FDA completed an inspection of Fresenius USA Manufacturing, Inc. on August 18, 2017 in Ogden, UT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 18, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Ogden, UT (United States)

Facility

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  • 1015295 (NAI Thu May 18 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 861872 (VAI Fri Jan 10 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

FDA data resources