FDA-Inspected Site

The Keeper/ Moon Cup Inc.

3 FDA inspections are on record for The Keeper/ Moon Cup Inc. in Cincinnati, United States.

483· Form 483 issued

Cincinnati, United States · Last updated July 10, 2026

Overview

  • 3 FDA inspections are on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2015-08-10.

At a glance

Inspections

3

Form 483s

1

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
6 Aug 2015 – 10 Aug 2015Medical Devices & Rad Health483View 483 →
31 Mar 2011Not recordedClean
2 Jul 2008Not recordedClean

Observations on record

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

10 Aug 2015
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Brigitte K Strelnik

10 Aug 2015
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Brigitte K Strelnik

10 Aug 2015
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Brigitte K Strelnik

10 Aug 2015
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Brigitte K Strelnik

10 Aug 2015
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Brigitte K Strelnik

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 803.17Cited across public-safe Form 483 observations2x
21 CFR 820.100(a)Cited across public-safe Form 483 observations2x
21 CFR 820.198(a)Cited across public-safe Form 483 observations2x
21 CFR 820.25(b)Cited across public-safe Form 483 observations2x
21 CFR 820.50Cited across public-safe Form 483 observations2x

Full site report

Get the verbatim findings behind The Keeper/ Moon Cup Inc.'s 1 Form 483

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