FDA-Inspected Site

Dr. Brown's Company

3 FDA inspections are on record for Dr. Brown's Company in Saint Louis, United States.

483· Form 483 issued

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

Overview

  • 3 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-04-23.

At a glance

Inspections

3

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
20 Apr 2026 – 23 Apr 2026Medical Devices & Rad Health483View 483 →
25 Oct 2013 – 31 Oct 2013Medical Devices & Rad Health483View 483 →
23 Feb 2011Not recordedClean

Observations on record

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

23 Apr 2026
21 CFR 820.35(a)

Lack of justification for not investigating complaints requiring investigation

Cited by Edward E Lockwood

23 Apr 2026
ISO 13485:2016 Clause 7.4.2

Purchasing information does not include all required elements

Cited by Edward E Lockwood

23 Apr 2026
ISO 13485:2016 Clause 7.5.6

Process for production and service provision not validated

Cited by Edward E Lockwood

23 Apr 2026
ISO 13485:2016 Clause 8.2.6

Monitoring and measurement requirements of product characteristics are not met

Cited by Edward E Lockwood

31 Oct 2013
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Shafiq Ahadi

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 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.184Cited across public-safe Form 483 observations1x
21 CFR 820.35(a)Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.4.2Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.5.6Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 8.2.6Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Dr. Brown's Company's 2 Form 483s

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