Form 483

Thorn BioScience Form 483, 2011-01-31

FDA issued a Form 483 to Thorn BioScience on 2011-01-31 with 1 public-safe observation.

483· Form 483 issued1 observation

Thorn BioScience · Louisville, United States · Issued January 31, 2011

Overview

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

Inspectional observations

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

31 Jan 2011
21 CFR 211.188

Prepared for each batch, include complete information

Cited by Kathleen D Culver

Inspected site

TBThorn BioScienceLouisville, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.188Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

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