Atlas

Form 483

B. Braun Medical, Inc. Form 483, 2012-12-13

FDA issued a Form 483 to B. Braun Medical, Inc. on 2012-12-13 with 2 public-safe observations.

483· Form 483 issued2 observations

B. Braun Medical, Inc. · Allentown, United States · Issued December 13, 2012

Overview

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

Inspectional observations

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

13 Dec 2012
21 CFR 820.75(b)(2)

Documentation of validated process performance

Cited by Brian S Keefer

13 Dec 2012
21 CFR 820.100(b)

Documentation

Cited by Brian S Keefer

Inspected site

BBB. Braun Medical, Inc.Allentown, United States

Inspection team

BSBrian S Keefer

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(b)Cited across public-safe Form 483 observations1x
21 CFR 820.75(b)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 observations

Every observation in full, 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