FDA-Inspected Site

Reese Pharmaceutical Company

10 FDA inspections are on record for Reese Pharmaceutical Company in Cleveland, United States.

Clean· No action indicated

Cleveland, United States · Last updated July 10, 2026

Overview

  • 10 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-09-25.

At a glance

Inspections

10

Form 483s

3

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
24 Sep 2025 – 25 Sep 2025Human DrugsClean
9 Dec 2021Foods & CosmeticsClean
1 Dec 2021 – 8 Dec 2021Foods & CosmeticsClean
5 Jun 2017Foods & CosmeticsClean
24 Apr 2017 – 25 Apr 2017Foods & CosmeticsClean
11 Jan 2012Not recorded483View 483 →
24 Nov 2010Not recordedWLView 483 →
4 Aug 2009Not recorded483View 483 →
19 May 2006Not recordedClean
29 Sep 2004Not recordedClean

Observations on record

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

11 Jan 2012
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Andrew J Lang

11 Jan 2012
21 CFR 211.125(a)

Strict control not exercised over labeling issued

Cited by Andrew J Lang

11 Jan 2012
21 CFR 211.180(e)(1)

Review of representative number of batches

Cited by Andrew J Lang

11 Jan 2012
21 CFR 211.186(b)(9)

Complete instructions, procedures, specifications et. al.

Cited by Andrew J Lang

11 Jan 2012
21 CFR 211.188(b)(6)

Inspection of packaging and labeling area

Cited by Andrew J Lang

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 211.100(b)Cited across public-safe Form 483 observations3x
21 CFR 211.125(a)Cited across public-safe Form 483 observations3x
21 CFR 211.186(b)(9)Cited across public-safe Form 483 observations2x
21 CFR 211.192Cited across public-safe Form 483 observations2x
21 CFR 211.115(a)Cited across public-safe Form 483 observations1x
21 CFR 211.130(b)Cited across public-safe Form 483 observations1x
21 CFR 211.130(c)Cited across public-safe Form 483 observations1x
21 CFR 211.134(a)Cited across public-safe Form 483 observations1x
21 CFR 211.170(b)Cited across public-safe Form 483 observations1x
21 CFR 211.180(e)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.184(d)Cited across public-safe Form 483 observations1x
21 CFR 211.186(a)Cited across public-safe Form 483 observations1x
21 CFR 211.188Cited across public-safe Form 483 observations1x
21 CFR 211.188(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 211.188(b)(8)Cited across public-safe Form 483 observations1x
21 CFR 211.196Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.80(d)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Reese Pharmaceutical Company's 3 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