FDA-Inspected Site

Mendell Machine and Manufacturing LLC

4 FDA inspections are on record for Mendell Machine and Manufacturing LLC in Lakeville, United States.

483· Form 483 issued

Lakeville, United States · Last updated August 15, 2026

Overview

  • 4 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-05-30.

At a glance

Inspections

4

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
21 May 2025 – 30 May 2025Medical Devices & Rad Health483View 483 →
27 Jul 2022 – 3 Aug 2022Medical Devices & Rad Health483View 483 →
23 Jul 2018Medical Devices & Rad HealthClean
12 Nov 2014 – 13 Nov 2014Medical Devices & Rad HealthClean

Observations on record

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

30 May 2025
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Albert L Nguyen

30 May 2025
21 CFR 820.40(b)

Document change records, maintained.

Cited by Albert L Nguyen

3 Aug 2022
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Joseph D Gong

3 Aug 2022
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Joseph D Gong

3 Aug 2022
21 CFR 820.40(b)

Document change records, maintained.

Cited by Joseph D Gong

Investigators

FDA investigators tied to this site in the record.

Kyle J Mccracken1 insp.

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 observations5x
21 CFR 820.40(b)Cited across public-safe Form 483 observations5x

Full site report

Get the verbatim findings behind Mendell Machine and Manufacturing LLC'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