FDA-Inspected Site

IKI Mfg Co., Inc

5 FDA inspections are on record for IKI Mfg Co., Inc in Edgerton, United States.

Clean· No action indicated

Edgerton, United States · Last updated August 15, 2026

Overview

  • 5 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2010-11-04.

At a glance

Inspections

5

Form 483s

2

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
4 Nov 2010Not recordedClean
13 Apr 2010Not recorded483View 483 →
6 May 2009Not recorded483View 483 →
17 Aug 2007Not recordedClean
21 Sep 2001Not recordedClean

Observations on record

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

13 Apr 2010
21 CFR 211.25(a)

Training--operations, GMPs, written procedures

Cited by Justin A Boyd

13 Apr 2010
21 CFR 211.56(a)

Sanitation--buildings not clean, free of infestation

Cited by Justin A Boyd

13 Apr 2010
21 CFR 211.100(a)

Approval and review of procedures

Cited by Justin A Boyd

13 Apr 2010
21 CFR 211.111

Establishment of time limitations

Cited by Justin A Boyd

13 Apr 2010
21 CFR 211.160(a)

Lab controls established, including changes

Cited by Justin A Boyd

Investigators

FDA investigators tied to this site in the record.

Charles Cote2 insp.
Kailas Nagaraj1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.160(b)Cited across public-safe Form 483 observations2x
21 CFR 211.25(a)Cited across public-safe Form 483 observations2x
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.111Cited across public-safe Form 483 observations1x
21 CFR 211.160(a)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.56(a)Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind IKI Mfg Co., Inc's 2 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