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Company
•United States

MSD International GmbH (Puerto Rico Branch) LLC, Las Piedras, PR – FDA Inspections

Inspection records and compliance data for MSD International GmbH (Puerto Rico Branch) LLC in Las Piedras, Puerto Rico. 6 FDA inspections on record, 2 Form 483s, last inspected September 10, 2025.

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Company Profile

This profile covers MSD International GmbH (Puerto Rico Branch) LLC based in Las Piedras, Puerto Rico, United States.

FDA Inspection History

FDA inspections
6
OAI
0
VAI
3
NAI
2
Unclassified
1
Form 483s
2
Warning letters
0

First inspected March 3, 2011. Last inspected September 10, 2025.

Most cited issue areas

  • Extent of discrepancy, failure investigations1 inspection
  • Failure to meet specifications1 inspection

FDA inspections (6)

DateResultFDA center(s)Insp. #
September 10, 2025Not classifiedHuman Drugs1282038
February 26, 2020VAIHuman Drugs · Drug Quality Assurance1117824
February 21, 2018VAIHuman Drugs · Drug Quality Assurance1046681
July 22, 2015NAIHuman Drugs · Drug Quality Assurance942032
May 9, 2013NAIHuman Drugs · Drug Quality Assurance832113
March 3, 2011VAIHuman Drugs · Drug Quality Assurance712810
FDA documents

Form 483s (2)

  • Form 483s · September 10, 2025
  • Form 483s · February 26, 2020

EIRs (2)

  • EIRs · February 26, 2020
  • EIRs · February 21, 2018
People (3)
Libia M. Lugo Leon
Person
Vilmary Negrón Rodríguez
Person
Marian E. Ramirez
Person
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Company Information

Name

MSD International GmbH (Puerto Rico Branch) LLC

FEI Number

2650155

Address

Pridco Indus Park, Sr 183, Las Piedras, Puerto Rico 00771, United States

Country

United States

ID: 98d0fc68-f819-4431-899c-0483c3329777

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Contact
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370 Jay Street 7th Floor
Brooklyn, NY 11201
Scranton Office:
Scranton Enterprise Center, Suite 217
201 Lackawanna Avenue
Scranton, PA, 18503
🇺🇸+1 917-789-5099
🇪🇺+48 532-447-507
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