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R&D Engineering, Inc. Of Earlham FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Latest inspection NAI · Apr 23, 2025
Last warning letter 2014

Inspections 5

0 OAI

Recalls 0 0 Class I

Warning letters 1 Latest May 16, 2014

510(k) clearances 0 None on file

R&D Engineering, Inc. Of Earlham has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to R&D Engineering, Inc. Of Earlham, the most recent on May 16, 2014.

What these totals cover: FDA records filed under the name "R&D Engineering, Inc. Of Earlham" and its spelling variant "R And D Engineering, Inc. Of Earlham".

Latest inspection: Apr 23, 2025 · NAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	5	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

R&D Engineering, Inc. Of Earlham's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

R&D Engineering, Inc. Of Earlham: FDA inspections per year

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	1	0	0	0	0
2024	0	0	0	0	0
2023	0	0	0	0	0
2022	1	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	0	0	0	0	0
2018	1	0	0	0	0
2017	0	0	0	0	0

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

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R&D Engineering, Inc. Of Earlham FDA Warning Letters

1 warning letter on May 16, 2014.

Issued	Subject	Issuing office	Close-out letter
May 16, 2014 · Record page

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

Recent FDA inspections

5 inspections from Feb 15, 2013 to Apr 23, 2025.

Date	Site	Product	Classification	FEI
Apr 23, 2025	Earlham, IA	Devices	No Action Indicated (NAI)	3009418685
Dec 15, 2022	Earlham, IA	Devices	No Action Indicated (NAI)	3009418685
Jan 10, 2018	Earlham, IA	Devices	No Action Indicated (NAI)	3009418685
Oct 10, 2014	Earlham, IA	Devices	Voluntary Action Indicated (VAI)	3009418685
Feb 15, 2013	Earlham, IA	Devices	No Action Indicated (NAI)	3009418685

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under R&D Engineering, Inc. Of Earlham: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, May 16, 2014.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3009418685	Earlham, IA	5	Apr 23, 2025

R&D Engineering, Inc. Of Earlham and the FDA: common questions

Has R&D Engineering, Inc. Of Earlham received an FDA warning letter?

Yes. FDA has issued 1 warning letter to R&D Engineering, Inc. Of Earlham. The most recent is dated May 16, 2014.

Has R&D Engineering, Inc. Of Earlham received an FDA Form 483?

FDA has not published a Form 483 for "R&D Engineering, Inc. Of Earlham" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect R&D Engineering, Inc. Of Earlham?

The most recent FDA inspection on file ended Apr 23, 2025 at Earlham, IA and was classified NAI. FDA has 5 inspections of R&D Engineering, Inc. Of Earlham on file.

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