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R And D Engineering Inc Of Earlham FDA Inspection Record

FEI 3009418685 · Inspections, Form 483s, warning letters and import refusals

R And D Engineering Inc Of Earlham is an FDA-registered facility (FEI 3009418685) located in Earlham, IA, US. RegDataLab tracks 5 FDA inspections and 1 compliance action at this facility.

What FDA found at this site

Latest inspection
Apr 23, 2025: No Action Indicated (NAI)
Inspections on record
5 (1 VAI, 4 NAI)
Last OAI inspection
None on record
Warning letters
1 listed by FDA for this FEI, latest May 16, 2014

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Apr 23, 2025No Action Indicated (NAI)Quality Audit/Reaudit - conducted (21 CFR 820.22)
Dec 15, 2022No Action Indicated (NAI)Lack of or inadequate DHR procedures (21 CFR 820.184)
Not approved or obsolete document retrieval (21 CFR 820.40(a))
Jan 10, 2018No Action Indicated (NAI)Lack of or inadequate process validation (21 CFR 820.75(a))
Oct 10, 2014Voluntary Action Indicated (VAI)DHR - not or inadequately maintained (21 CFR 820.184)
Design changes - Lack of or Inadequate Procedures (21 CFR 820.30(i))
Investigation of device failures (21 CFR 820.198(c))
DMR - not or inadequately maintained (21 CFR 820.181)
Feb 15, 2013No Action Indicated (NAI)No citations listed

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
R&D Engineering, Inc. Of Earlham
Location
Earlham, IA (US)
Source
device

Compliance actions

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.