Atlas

FDA-Inspected Site

Laboratorios Sophia, S.A. De C.V.

2 FDA inspections are on record for Laboratorios Sophia, S.A. De C.V. in Zapopan, Mexico.

483· Form 483 issued

Zapopan, 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 2018-12-14.

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 Dec 2018 – 14 Dec 2018Human Drugs483View 483 →
24 Aug 2015 – 28 Aug 2015Human Drugs483On file

Observations on record

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

14 Dec 2018
21 CFR 111.105(b)

Quality control - supplier qualification

Cited by Alan P Kurtzberg

14 Dec 2018
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Alan P Kurtzberg

14 Dec 2018
21 CFR 211.100(b)

Procedure Deviations Recorded and Justified

Cited by Alan P Kurtzberg

Investigators

FDA investigators tied to this site in the record.

Alan P Kurtzberg1 insp.
Rafael Nevarez Nieves1 insp.
Ana P Pineda Zavaleta1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 111.105(b)Cited across public-safe Form 483 observations1x
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.113(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Laboratorios Sophia, S.A. De C.V.'s 2 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