FDA-Inspected Site

Omnilife Manufactura S.A. de C.V.

2 FDA inspections are on record for Omnilife Manufactura S.A. de C.V. in Tlaquepaque, Mexico.

483· Form 483 issued

Tlaquepaque, Mexico · Last updated July 10, 2026

Overview

  • 2 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2018-12-06.

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
4 Dec 2018 – 6 Dec 2018Foods & Cosmetics483View 483 →
27 Nov 2012Not recorded483View 483 →

Observations on record

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

6 Dec 2018
21 CFR 111.60(a)

Production, in- process control system - design, quality

Cited by Dariusz Galezowski, Leslie D Hintz

27 Nov 2012
21 CFR 111.77(a)

Specifications not met - reject, quality control

Cited by Edward P Potter

27 Nov 2012
21 CFR 111.210(h)(3)(ii)(B)

Components; add, verify

Cited by Edward P Potter

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 111.210(h)(3)(ii)(B)Cited across public-safe Form 483 observations1x
21 CFR 111.60(a)Cited across public-safe Form 483 observations1x
21 CFR 111.77(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Omnilife Manufactura 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