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Form 483

Bio-Rad Laboratories, Inc. Form 483, 2025-01-31

FDA issued a Form 483 to Bio-Rad Laboratories, Inc. on 2025-01-31 with 1 public-safe observation.

483· Form 483 issuedBiologics1 observation

Bio-Rad Laboratories, Inc. · Woodinville, United States · Issued January 31, 2025

Overview

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

Inspectional observations

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

31 Jan 2025
21 CFR 820.100(b)

Documentation

Cited by Creighton T Tuzon, Kaarin M Slotte

Inspected site

BLBio-Rad Laboratories, Inc.Woodinville, United States

Inspection team

CTCreighton T Tuzon
KMKaarin M Slotte

Cited regulations

CFR citations associated with this Form 483.

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

Source document

PDF
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Form 483 source document

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Full 483 report

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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