FDA-Inspected Site

BioAgilytix

2 FDA inspections are on record for BioAgilytix in Hamburg, Germany.

Clean· No action indicated

Hamburg, Germany · Last updated July 10, 2026

Overview

  • 2 FDA inspections are on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2019-06-07.

At a glance

Inspections

2

Form 483s

1

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
3 Jun 2019 – 7 Jun 2019Human DrugsClean
26 Feb 2018 – 2 Mar 2018Human Drugs483On file

Investigators

FDA investigators tied to this site in the record.

Full site report

Get the verbatim findings behind BioAgilytix's 1 Form 483

The full inspection record, as Atlas holds it, 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