Atlas

FDA-Inspected Site

Zermat Internacional, S.A. de C.V.

2 FDA inspections are on record for Zermat Internacional, S.A. de C.V. in Tlalnepantla, Mexico.

483· Form 483 issued

Tlalnepantla, Mexico · Last updated July 11, 2026

Overview

  • 2 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2022-10-14.

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
10 Oct 2022 – 14 Oct 2022Human DrugsWLView 483 →
8 Sep 2014 – 12 Sep 2014Human Drugs483View 483 →

Observations on record

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

14 Oct 2022
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Christopher M Jenner, Tiara M Brown

14 Oct 2022
21 CFR 211.160(b)(1)

Incoming lots - conformance to written specs-

Cited by Christopher M Jenner, Tiara M Brown

14 Oct 2022
21 CFR 211.188(b)

Batch production and Batch Control Record Requirements

Cited by Christopher M Jenner, Tiara M Brown

14 Oct 2022
21 CFR 211.22(a)

Lack of quality control unit

Cited by Christopher M Jenner, Tiara M Brown

14 Oct 2022
21 CFR 211.68(b)

Backup data not assured as exact and complete

Cited by Christopher M Jenner, Tiara M Brown

Investigators

FDA investigators tied to this site in the record.

Christopher M Jenner1 insp.
Tiara M Brown1 insp.
Heriberto Negron-Rivera1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.137(a)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.188(b)Cited across public-safe Form 483 observations1x
21 CFR 211.22(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x
21 CFR 211.68(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Zermat Internacional, S.A. de C.V.'s 2 Form 483s

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