FDA-Inspected Site

Ko Ko International

6 FDA inspections are on record for Ko Ko International in Rockville, United States.

483· Form 483 issued

Rockville, United States · Last updated July 9, 2026

Overview

  • 6 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2019-08-22.

At a glance

Inspections

6

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
21 Aug 2019 – 22 Aug 2019Foods & Cosmetics483View 483 →
1 Feb 2018Foods & CosmeticsClean
4 Mar 2015Foods & CosmeticsClean
29 Aug 2013Foods & CosmeticsClean
8 Mar 2010Not recorded483On file
26 Mar 2007Not recordedClean

Observations on record

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

22 Aug 2019
21 CFR 117.35(a)

Sanitary Operations - Plant Maintenance

Cited by Jennifer L Barre

22 Aug 2019
21 CFR 117.35(c)

Pest Control

Cited by Jennifer L Barre

22 Aug 2019
21 CFR 117.4

Training of employees and records

Cited by Jennifer L Barre

Investigators

FDA investigators tied to this site in the record.

State Agency3 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 117.35(a)Cited across public-safe Form 483 observations1x
21 CFR 117.35(c)Cited across public-safe Form 483 observations1x
21 CFR 117.4Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Ko Ko International'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