MSD International GmbH (Puerto Rico Branch) LLC FDA Record
- Latest inspection VAI · Sep 10, 2025
- No warning letters matched by name
MSD International GmbH (Puerto Rico Branch) LLC has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "MSD International GmbH (Puerto Rico Branch) LLC" is on file.
- Latest inspection
- Sep 10, 2025 · VAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 6 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
MSD International GmbH (Puerto Rico Branch) LLC: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 1 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Sep 10, 2025 | Las Piedras, PR | Drugs | Voluntary Action Indicated (VAI) | 2650155 |
| Feb 26, 2020 | Las Piedras, PR | Drugs | Voluntary Action Indicated (VAI) | 2650155 |
| Feb 21, 2018 | Las Piedras, PR | Drugs | Voluntary Action Indicated (VAI) | 2650155 |
| Jul 22, 2015 | Las Piedras, PR | Drugs | No Action Indicated (NAI) | 2650155 |
| May 9, 2013 | Las Piedras, PR | Drugs | No Action Indicated (NAI) | 2650155 |
| Mar 3, 2011 | Las Piedras, PR | Drugs | Voluntary Action Indicated (VAI) | 2650155 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 2650155 | Las Piedras, PR | 6 | Sep 10, 2025 |
MSD International GmbH (Puerto Rico Branch) LLC and the FDA: common questions
Has MSD International GmbH (Puerto Rico Branch) LLC received an FDA warning letter?
No FDA warning letter addressed to the name "MSD International GmbH (Puerto Rico Branch) LLC" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has MSD International GmbH (Puerto Rico Branch) LLC received an FDA Form 483?
FDA has not published a Form 483 for "MSD International GmbH (Puerto Rico Branch) LLC" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect MSD International GmbH (Puerto Rico Branch) LLC?
The most recent FDA inspection on file ended Sep 10, 2025 at Las Piedras, PR and was classified VAI. FDA has 6 inspections of MSD International GmbH (Puerto Rico Branch) LLC on file.
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