FDA-Inspected Site

Ionetix Corporation

2 FDA inspections are on record for Ionetix Corporation in Sarasota, United States.

483· Form 483 issued

Sarasota, 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 2026-04-02.

At a glance

Inspections

2

Form 483s

2

EIRs

1

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
30 Mar 2026 – 2 Apr 2026Human Drugs483View 483 →
21 Oct 2019 – 25 Oct 2019Human Drugs483View 483 →

Observations on record

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

2 Apr 2026
21 CFR 212.20(c)

Specifications and processes

Cited by Joanne E King

2 Apr 2026
21 CFR 212.30(b)

Equipment procedures

Cited by Joanne E King

2 Apr 2026
21 CFR 212.40(c)

Use of reliable suppliers

Cited by Joanne E King

2 Apr 2026
21 CFR 212.50(a)

Written control procedures

Cited by Joanne E King

25 Oct 2019
21 CFR 212.20(e)

Written QA procedures established, followed

Cited by Noreen Muniz

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 212.30(b)Cited across public-safe Form 483 observations3x
21 CFR 212.20(e)Cited across public-safe Form 483 observations2x
21 CFR 212.50(b)Cited across public-safe Form 483 observations2x
21 CFR 212.60(f)Cited across public-safe Form 483 observations2x
21 CFR 212.20(c)Cited across public-safe Form 483 observations1x
21 CFR 212.40(c)Cited across public-safe Form 483 observations1x
21 CFR 212.50(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Ionetix Corporation'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