Atlas

FDA-Inspected Site

Laboratorios Jaloma S.A. de C.V.

5 FDA inspections are on record for Laboratorios Jaloma S.A. de C.V. in Guadalajara, Mexico.

483· Form 483 issued

Guadalajara, Mexico · Last updated August 15, 2026

Overview

  • 5 FDA inspections are on record.
  • 5 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-12-19.

At a glance

Inspections

5

Form 483s

5

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
15 Dec 2025 – 19 Dec 2025Human DrugsWLView 483 →
3 Dec 2018 – 7 Dec 2018Human Drugs483View 483 →
5 Sep 2016 – 9 Sep 2016Human Drugs483View 483 →
12 Aug 2013 – 15 Aug 2013Human Drugs483On file
29 Sep 2011Not recordedWLOn file

Observations on record

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

19 Dec 2025
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Tamil Arasu, Jose M Cayuela

19 Dec 2025
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Tamil Arasu, Jose M Cayuela

19 Dec 2025
21 CFR 211.194(a)

Complete test data included in records

Cited by Tamil Arasu, Jose M Cayuela

19 Dec 2025
21 CFR 211.68(b)

Computer control of master formula records

Cited by Tamil Arasu, Jose M Cayuela

7 Dec 2018
21 CFR 111.105(b)

Quality control - supplier qualification

Cited by Alan P Kurtzberg

Investigators

FDA investigators tied to this site in the record.

Tamil Arasu1 insp.
Jose M Cayuela1 insp.
Alan P Kurtzberg1 insp.
Saied A Asbagh1 insp.
Tara L Greene1 insp.
Felix Maldonado1 insp.
Jose R Hernandez1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.188Cited across public-safe Form 483 observations2x
21 CFR 211.52Cited across public-safe Form 483 observations2x
21 CFR 211.68(b)Cited across public-safe Form 483 observations2x
21 CFR 211.80(b)Cited across public-safe Form 483 observations2x
21 CFR 211.80(d)Cited across public-safe Form 483 observations2x
21 CFR 111.105(b)Cited across public-safe Form 483 observations1x
21 CFR 211.103Cited across public-safe Form 483 observations1x
21 CFR 211.122(d)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.180(e)Cited across public-safe Form 483 observations1x
21 CFR 211.182Cited across public-safe Form 483 observations1x
21 CFR 211.186(a)Cited across public-safe Form 483 observations1x
21 CFR 211.186(b)(9)Cited across public-safe Form 483 observations1x
21 CFR 211.188(b)(12)Cited across public-safe Form 483 observations1x
21 CFR 211.188(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(7)Cited across public-safe Form 483 observations1x
21 CFR 211.56(a)Cited across public-safe Form 483 observations1x
21 CFR 211.80(c)Cited across public-safe Form 483 observations1x
21 CFR 211.84(c)(6)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Laboratorios Jaloma S.A. de C.V.'s 5 Form 483s

Source PDFs, 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