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Form 483

Comparative Biosciences, Inc Form 483, 2019-05-17

FDA issued a Form 483 to Comparative Biosciences, Inc on 2019-05-17 with 4 public-safe observations.

483· Form 483 issuedHuman Drugs4 observations

Comparative Biosciences, Inc · Sunnyvale, United States · Issued May 17, 2019

Overview

  • 4 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.

17 May 2019
21 CFR 58.105(c)

Test article: storage container labeling

Cited by Dustin P Tran

17 May 2019
21 CFR 58.83

Reagents: labeling

Cited by Dustin P Tran

17 May 2019
21 CFR 58.105(c)

Test article: storage container labeling

Cited by Dustin P Tran

17 May 2019
21 CFR 58.83

Reagents: labeling

Cited by Dustin P Tran

Inspected site

CBComparative Biosciences, IncSunnyvale, United States

Inspection team

DPDustin P Tran

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 58.105(c)Cited across public-safe Form 483 observations2x
21 CFR 58.83Cited across public-safe Form 483 observations2x

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 4 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