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Form 483

B. Braun US Pharmaceutical Manufacturing, LLC Form 483, 2020-07-23

FDA issued a Form 483 to B. Braun US Pharmaceutical Manufacturing, LLC on 2020-07-23 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

B. Braun US Pharmaceutical Manufacturing, LLC · Irvine, United States · Issued July 23, 2020

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

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

23 Jul 2020
21 CFR 211.192

Written record of investigation incomplete

Cited by Uttaniti Limchumroon, Walden H Lee

23 Jul 2020
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Uttaniti Limchumroon, Walden H Lee

23 Jul 2020
21 CFR 211.65(a)

Equipment construction - reactive surfaces

Cited by Uttaniti Limchumroon, Walden H Lee

Inspected site

BBB. Braun US Pharmaceutical Manufacturing, LLCIrvine, United States

Inspection team

ULUttaniti Limchumroon
WHWalden H Lee

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.65(a)Cited across public-safe Form 483 observations1x

Source document

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Form 483 source document

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Full 483 report

Get the verbatim text of all 3 observations

The source PDF, so your team sees exactly what was cited and how it was answered.

  • 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