FDA-Inspected Site

Magnatone Hearing Aid Corp

4 FDA inspections are on record for Magnatone Hearing Aid Corp in Casselberry, United States.

483· Form 483 issued

Casselberry, United States · Last updated August 15, 2026

Overview

  • 4 FDA inspections are on record.
  • 4 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-07-14.

At a glance

Inspections

4

Form 483s

4

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
9 Jul 2025 – 14 Jul 2025Medical Devices & Rad Health483View 483 →
3 Dec 2019 – 10 Dec 2019Medical Devices & Rad Health483View 483 →
13 Jul 2017 – 14 Jul 2017Medical Devices & Rad Health483View 483 →
23 Jun 2016 – 27 Jun 2016Medical Devices & Rad Health483View 483 →

Observations on record

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

14 Jul 2025
21 CFR 803.17(a)(2)

Lack of System for Determining MDR Events

Cited by Ulysses D Singleton

14 Jul 2025
21 CFR 803.17(a)(2)

Lack of System for Determining MDR Events

Cited by Ulysses D Singleton

14 Jul 2025
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Ulysses D Singleton

14 Jul 2025
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Ulysses D Singleton

14 Jul 2025
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Ulysses D Singleton

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 observations6x
21 CFR 820.198(a)Cited across public-safe Form 483 observations6x
21 CFR 820.50Cited across public-safe Form 483 observations6x
21 CFR 803.17(a)(2)Cited across public-safe Form 483 observations4x
21 CFR 820.30(g)Cited across public-safe Form 483 observations4x
21 CFR 803.17Cited across public-safe Form 483 observations2x
21 CFR 820.20(a)Cited across public-safe Form 483 observations2x
21 CFR 820.22Cited across public-safe Form 483 observations2x
21 CFR 820.30(c)Cited across public-safe Form 483 observations2x
21 CFR 820.30(i)Cited across public-safe Form 483 observations2x
21 CFR 820.40(b)Cited across public-safe Form 483 observations2x
21 CFR 820.70(a)Cited across public-safe Form 483 observations2x
21 CFR 820.80(d)Cited across public-safe Form 483 observations2x

Full site report

Get the verbatim findings behind Magnatone Hearing Aid Corp's 4 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