FDA Inspection
MSD International GmbH (Puerto Rico Branch) LLCMSD International GmbH (Puerto Rico Branch) LLC – FDA Inspection, Feb 26, 2020
Record Details
This FDA Inspection record concerns MSD International GmbH (Puerto Rico Branch) LLC, with an inspection on February 26, 2020, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- February 26, 2020
- Product Type
- Drugs
View Company Profile
ID · c29c089e-ab0c-4601-8020-f55e8dfc4069
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1117824
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
- 21 CFR 211.192Extent of discrepancy, failure investigations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of MSD International GmbH (Puerto Rico Branch) LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 10, 2025 | Not classified | San Juan District Office | |
| February 21, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 22, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 9, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 3, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for MSD International GmbH (Puerto Rico Branch) LLC
- FDA Inspection 1282038 - 2025-09-10
- FDA Inspection 1046681 - 2018-02-21
- FDA Inspection 942032 - 2015-07-22
- FDA Inspection 832113 - 2013-05-09
- FDA Inspection 712810 - 2011-03-03
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.