Atlas

FDA-Inspected Site

Chemisphere Corporation

8 FDA inspections are on record for Chemisphere Corporation in Saint Louis, United States.

483· Form 483 issued

Saint Louis, United States · Last updated July 10, 2026

Overview

  • 8 FDA inspections are on record.
  • 4 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-06-24.

At a glance

Inspections

8

Form 483s

4

EIRs

1

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
16 Jun 2025 – 24 Jun 2025Human DrugsWLOn file
16 Mar 2020 – 17 Mar 2020Human Drugs483On file
15 Apr 2015 – 8 May 2015Medical Devices & Rad HealthClean
16 Sep 2011Not recorded483View 483 →
5 Apr 2010Not recorded483View 483 →
12 Feb 2007Not recordedClean
2 Jul 2004Not recordedClean
17 Sep 2003Not recordedClean

Observations on record

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

16 Sep 2011
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Steven D Kehoe

16 Sep 2011
21 CFR 211.25(a)

Training--operations, GMPs, written procedures

Cited by Steven D Kehoe

16 Sep 2011
21 CFR 211.58

Buildings not maintained in good state of repair

Cited by Steven D Kehoe

16 Sep 2011
21 CFR 211.63

Equipment Design, Size and Location

Cited by Steven D Kehoe

16 Sep 2011
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Steven D Kehoe

Investigators

FDA investigators tied to this site in the record.

Steven D Kehoe2 insp.
Mary L Schuckmann1 insp.
Eric D Bowles1 insp.
Alan M Roberts1 insp.
Shafiq Ahadi1 insp.
Eric M Padgett1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations2x
21 CFR 211.160(a)Cited across public-safe Form 483 observations2x
21 CFR 211.25(a)Cited across public-safe Form 483 observations2x
21 CFR 211.67(b)Cited across public-safe Form 483 observations2x
21 CFR 211.84(d)(2)Cited across public-safe Form 483 observations2x
21 CFR 820.30(i)Cited across public-safe Form 483 observations2x
21 CFR 211.103Cited across public-safe Form 483 observations1x
21 CFR 211.150Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.165(e)Cited across public-safe Form 483 observations1x
21 CFR 211.186(a)Cited across public-safe Form 483 observations1x
21 CFR 211.186(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 211.188Cited across public-safe Form 483 observations1x
21 CFR 211.188(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(8)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.58Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(c)Cited across public-safe Form 483 observations1x
21 CFR 211.68(a)Cited across public-safe Form 483 observations1x
21 CFR 211.80(a)Cited across public-safe Form 483 observations1x
21 CFR 211.80(d)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(6)Cited across public-safe Form 483 observations1x
21 CFR 820.20(e)Cited across public-safe Form 483 observations1x
21 CFR 820.60Cited across public-safe Form 483 observations1x
21 CFR 820.75(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Chemisphere Corporation's 4 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