FDA-Inspected Site

Molded Rubber and Plastic LLC (MRPC)

2 FDA inspections are on record for Molded Rubber and Plastic LLC (MRPC) in Butler, United States.

483· Form 483 issued

Butler, United States · Last updated August 15, 2026

Overview

  • 2 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-07-16.

At a glance

Inspections

2

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
13 Jul 2026 – 16 Jul 2026Medical Devices & Rad Health483View 483 →
10 Dec 2024 – 16 Dec 2024Medical Devices & Rad Health483View 483 →

Observations on record

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

16 Jul 2026
ISO 13485:2016 Clause 6.4.1

Work environment requirements and procedures not documented

Cited by Jesse A Vazquez, Shuana H Xiong

16 Jul 2026
ISO 13485:2016 Clause 7.1

Product realization risk management processes not documented

Cited by Jesse A Vazquez, Shuana H Xiong

16 Jul 2026
ISO 13485:2016 Clause 7.4.1

Supplier performance not monitored

Cited by Jesse A Vazquez, Shuana H Xiong

16 Dec 2024
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Chad E Schmear

16 Dec 2024
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Chad E Schmear

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 820.100(a)Cited across public-safe Form 483 observations2x
21 CFR 820.50Cited across public-safe Form 483 observations2x
21 CFR 820.75(a)Cited across public-safe Form 483 observations2x
21 CFR 820.90(a)Cited across public-safe Form 483 observations2x
ISO 13485:2016 Clause 6.4.1Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.1Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.4.1Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Molded Rubber and Plastic LLC (MRPC)'s 2 Form 483s

Source PDFs 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