FDA-Inspected Site

Hepac B.V.

2 FDA inspections are on record for Hepac B.V. in Loenen Gld, Netherlands.

483· Form 483 issued

Loenen Gld, Netherlands · Last updated July 9, 2026

Overview

  • 2 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2017-09-22.

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
18 Sep 2017 – 22 Sep 2017Human Drugs483On file
30 Nov 2015 – 4 Dec 2015Human Drugs483On file

Investigators

FDA investigators tied to this site in the record.

Full site report

Get the verbatim findings behind Hepac B.V.'s 2 Form 483s

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