Atlas

FDA-Inspected Site

MSD International GmbH (Puerto Rico Branch) LLC

10 FDA inspections are on record for MSD International GmbH (Puerto Rico Branch) LLC in Las Piedras, United States.

483· Form 483 issued

Las Piedras, United States · Last updated July 10, 2026

Overview

  • 10 FDA inspections are on record.
  • 4 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-09-10.

At a glance

Inspections

10

Form 483s

4

EIRs

2

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
8 Sep 2025 – 10 Sep 2025Human Drugs483On file
5 Feb 2020 – 26 Feb 2020Human Drugs483View 483 →
1 Feb 2018 – 21 Feb 2018Human Drugs483On file
14 Jul 2015 – 22 Jul 2015Human DrugsClean
15 Apr 2013 – 9 May 2013Human DrugsClean
3 Mar 2011Not recorded483On file
5 May 2006Not recordedClean
19 Aug 2003Not recordedClean
5 Jun 2001Not recordedClean
16 Feb 2001Not recordedClean

Observations on record

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

26 Feb 2020
21 CFR 211.192

Extent of discrepancy, failure investigations

Cited by Vilmary Negron Rodriguez, Marian E Ramirez

26 Feb 2020
21 CFR 314.81(b)(1)(ii)

Failure to meet specifications

Cited by Vilmary Negron Rodriguez, Marian E Ramirez

Investigators

FDA investigators tied to this site in the record.

Marian E Ramirez2 insp.
Libia M Lugo2 insp.
Jose F Velez1 insp.
Vilmary Negron Rodriguez1 insp.
Samina S Khan1 insp.
German Rivera1 insp.
Jose E Melendez1 insp.
Iraida Ortiz1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 314.81(b)(1)(ii)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind MSD International GmbH (Puerto Rico Branch) LLC's 4 Form 483s

Source PDFs 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