FDA-Inspected Site

Organo Sintesis, S.A. De C.V.

3 FDA inspections are on record for Organo Sintesis, S.A. De C.V. in Capulhuac, Mexico.

483· Form 483 issued

Capulhuac, Mexico · Last updated August 15, 2026

Overview

  • 3 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2023-07-28.

At a glance

Inspections

3

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
24 Jul 2023 – 28 Jul 2023Human Drugs483On file
1 Aug 2016 – 5 Aug 2016Human DrugsClean
25 Oct 2012Not recorded483On file

Investigators

FDA investigators tied to this site in the record.

Full site report

Get the verbatim findings behind Organo Sintesis, S.A. De C.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