FDA-Inspected Site

R&D Engineering, Inc. of Earlham

6 FDA inspections are on record for R&D Engineering, Inc. of Earlham in Earlham, United States.

483· Form 483 issued

Earlham, United States · Last updated August 15, 2026

Overview

  • 6 FDA inspections are on record.
  • 5 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-04-23.

At a glance

Inspections

6

Form 483s

5

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
22 Apr 2025 – 23 Apr 2025Medical Devices & Rad Health483View 483 →
12 Dec 2022 – 15 Dec 2022Medical Devices & Rad Health483View 483 →
9 Jan 2018 – 10 Jan 2018Medical Devices & Rad Health483View 483 →
6 Oct 2014 – 10 Oct 2014Medical Devices & Rad Health483View 483 →
17 Apr 2014 – 25 Apr 2014Medical Devices & Rad Health483On file
13 Feb 2013 – 15 Feb 2013Medical Devices & Rad HealthClean

Observations on record

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

23 Apr 2025
21 CFR 820.22

Quality Audit/Reaudit - conducted

Cited by Clifford F Long

23 Apr 2025
21 CFR 820.22

Quality Audit/Reaudit - conducted

Cited by Clifford F Long

15 Dec 2022
21 CFR 820.184

Lack of or inadequate DHR procedures

Cited by Clifford F Long

15 Dec 2022
21 CFR 820.184

Lack of or inadequate DHR procedures

Cited by Clifford F Long

15 Dec 2022
21 CFR 820.40(a)

Not approved or obsolete document retrieval

Cited by Clifford F Long

Investigators

FDA investigators tied to this site in the record.

Candace S Tucker2 insp.
Eric C Fox1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.184Cited across public-safe Form 483 observations3x
21 CFR 820.22Cited across public-safe Form 483 observations2x
21 CFR 820.40(a)Cited across public-safe Form 483 observations2x
21 CFR 820.75(a)Cited across public-safe Form 483 observations2x
21 CFR 820.181Cited across public-safe Form 483 observations1x
21 CFR 820.198(c)Cited across public-safe Form 483 observations1x
21 CFR 820.30(i)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind R&D Engineering, Inc. of Earlham's 5 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