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Form 483

Thorn BioScience Form 483, 2023-05-26

FDA issued a Form 483 to Thorn BioScience on 2023-05-26 with 2 public-safe observations.

483· Form 483 issuedAnimal Drugs & Feeds2 observations

Thorn BioScience · Louisville, United States · Issued May 26, 2023

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.

26 May 2023
21 CFR 211.160(a)

Lab controls established, including changes

Cited by Logan T Williams

26 May 2023
21 CFR 211.180(e)(1)

Review of representative number of batches

Cited by Logan T Williams

Inspected site

TBThorn BioScienceLouisville, United States

Inspection team

LTLogan T Williams

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.160(a)Cited across public-safe Form 483 observations1x
21 CFR 211.180(e)(1)Cited 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, 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