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Form 483

Fresenius USA Manufacturing, Inc. Form 483, 2021-05-21

FDA issued a Form 483 to Fresenius USA Manufacturing, Inc. on 2021-05-21 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Fresenius USA Manufacturing, Inc. · Ogden, United States · Issued May 21, 2021

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

21 May 2021
21 CFR 211.192

Written record of investigation incomplete

Cited by Saied A Asbagh

Inspected site

FUFresenius USA Manufacturing, Inc.Ogden, United States

Inspection team

SASaied A Asbagh

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations1x

Source document

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Form 483 source document

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  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere