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Form 483

ThermoFisher Scientific Form 483, 2012-06-06

FDA issued a Form 483 to ThermoFisher Scientific on 2012-06-06 with 2 public-safe observations.

483· Form 483 issued2 observations

ThermoFisher Scientific · High Point, United States · Issued June 6, 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.

6 Jun 2012
21 CFR 111.353

Manufacturing operations - written procedures

Cited by Viviana Matta

6 Jun 2012
21 CFR 111.365

Manufacturing operations - prevent contamination

Cited by Viviana Matta

Inspected site

TSThermoFisher ScientificHigh Point, United States

Inspection team

VMViviana Matta

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.353Cited across public-safe Form 483 observations1x
21 CFR 111.365Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

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Full 483 report

Get the verbatim text of all 2 observations

The source PDF and 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