FDA-Inspected Site

Thorn BioScience

10 FDA inspections are on record for Thorn BioScience in Louisville, United States.

483· Form 483 issued

Louisville, United States · Last updated July 9, 2026

Overview

  • 10 FDA inspections are on record.
  • 9 inspections produced a Form 483.
  • The most recent recorded inspection date is 2024-05-22.

At a glance

Inspections

10

Form 483s

9

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
14 May 2024 – 22 May 2024Animal Drugs & Feeds483View 483 →
16 Jan 2024 – 19 Jan 2024Animal Drugs & Feeds483View 483 →
22 May 2023 – 26 May 2023Animal Drugs & Feeds483View 483 →
3 Jun 2019 – 7 Jun 2019Animal Drugs & Feeds483View 483 →
14 May 2018 – 23 May 2018Animal Drugs & Feeds483View 483 →
8 May 2017 – 15 May 2017Animal Drugs & Feeds483View 483 →
23 Feb 2015 – 26 Feb 2015Animal Drugs & Feeds483View 483 →
31 Jan 2011Not recorded483View 483 →
6 May 2010Not recorded483View 483 →
9 Mar 2004Not recordedClean

Observations on record

Form 483 observations cited at this site, most recent first.

22 May 2024
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Rafeeq A Habeeb

22 May 2024
21 CFR 211.170(a)

Reserve sample quantity - active ingredients only

Cited by Rafeeq A Habeeb

22 May 2024
21 CFR 211.182

Written records kept in individual logs

Cited by Rafeeq A Habeeb

22 May 2024
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Rafeeq A Habeeb

22 May 2024
21 CFR 211.42(c)(10)(v)

Cleaning System

Cited by Rafeeq A Habeeb

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.113(b)Cited across public-safe Form 483 observations5x
21 CFR 211.68(b)Cited across public-safe Form 483 observations5x
21 CFR 211.182Cited across public-safe Form 483 observations4x
21 CFR 211.100(a)Cited across public-safe Form 483 observations3x
21 CFR 211.105(a)Cited across public-safe Form 483 observations3x
21 CFR 211.160(b)(4)Cited across public-safe Form 483 observations3x
21 CFR 211.208Cited across public-safe Form 483 observations3x
21 CFR 211.22(a)Cited across public-safe Form 483 observations3x
21 CFR 211.25(a)Cited across public-safe Form 483 observations3x
21 CFR 211.42(c)(10)(v)Cited across public-safe Form 483 observations3x
21 CFR 211.84(e)Cited across public-safe Form 483 observations3x
21 CFR 211.160(a)Cited across public-safe Form 483 observations2x
21 CFR 211.165(d)Cited across public-safe Form 483 observations2x
21 CFR 211.165(e)Cited across public-safe Form 483 observations2x
21 CFR 211.188(b)(12)Cited across public-safe Form 483 observations2x
21 CFR 211.192Cited across public-safe Form 483 observations2x
21 CFR 211.194(a)(7)Cited across public-safe Form 483 observations2x
21 CFR 211.67(a)Cited across public-safe Form 483 observations2x
21 CFR 211.67(b)(2)Cited across public-safe Form 483 observations2x
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.165(f)Cited across public-safe Form 483 observations1x
21 CFR 211.170(a)Cited across public-safe Form 483 observations1x
21 CFR 211.180(b)Cited across public-safe Form 483 observations1x
21 CFR 211.180(e)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.186(b)(9)Cited across public-safe Form 483 observations1x
21 CFR 211.188Cited across public-safe Form 483 observations1x
21 CFR 211.188(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.194(e)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.80(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Thorn BioScience's 9 Form 483s

Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat