Atlas

FDA-Inspected Site

Selder, S.A. de C.V.

5 FDA inspections are on record for Selder, S.A. de C.V. in Ciudad De Mexico, Mexico.

483· Form 483 issued

Ciudad De Mexico, 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 2024-12-20.

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
16 Dec 2024 – 20 Dec 2024Human Drugs483View 483 →
28 May 2018 – 1 Jun 2018Human Drugs483View 483 →
8 Aug 2016 – 12 Aug 2016Human Drugs483On file
23 Sep 2013 – 27 Sep 2013Human Drugs483View 483 →
23 Sep 2011Not recordedWLOn file

Observations on record

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

20 Dec 2024
21 CFR 211.100(b)

Procedure Deviations Recorded and Justified

Cited by Matthew B Casale

1 Jun 2018
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Nicholas L Hunt

1 Jun 2018
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Nicholas L Hunt

1 Jun 2018
21 CFR 211.165(f)

Failing drug products not rejected

Cited by Nicholas L Hunt

27 Sep 2013
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Felix Maldonado, Maria P Kelly-Doggett

Investigators

FDA investigators tied to this site in the record.

Felix Maldonado2 insp.
Matthew B Casale1 insp.
Nicholas L Hunt1 insp.
Heriberto Negron-Rivera1 insp.
Maria P Kelly-Doggett1 insp.
Jose R Hernandez1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.160(b)Cited across public-safe Form 483 observations2x
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.103Cited across public-safe Form 483 observations1x
21 CFR 211.165(f)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)(3)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 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x
21 CFR 211.68(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Selder, S.A. de C.V.'s 5 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