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483
•MSD International GmbH (Puerto Rico Branch) LLC•September 10, 2025

FDA 483 - MSD International GmbH (Puerto Rico Branch) LLC - September 10, 2025

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Record Details

An FDA inspection of MSD International GmbH (Puerto Rico Branch) LLC in Las Piedras, PR, identified a critical quality system deficiency. The firm failed to adequately document investigations into out-of-specification (OOS) results for recalled finished drug products, specifically regarding batch record revisions and manufacturing process evaluations. This lapse in quality control led to product recalls and indicates a serious failure in their investigation procedures.

Company
MSD International GmbH (Puerto Rico Branch) LLC
Inspection Date
September 10, 2025
Product Type
Drugs
Office
San Juan District Office
People
  • Marian E. Ramirez (investigator)
  • Jose F. Velez
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ID · 0d3c0fec-df3c-4367-9109-9f5669376b0b

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