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

Source: https://www.keypedia.com/records/483/msd-international-gmbh-puerto-rico-branch-llc/0d3c0fec-df3c-4367-9109-9f5669376b0b

> FDA 483 for MSD International GmbH (Puerto Rico Branch) LLC on September 10, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MSD International GmbH (Puerto Rico Branch) LLC
- Inspection Date: 2025-09-10
- Product Type: drugs
- Office Name: San Juan District Office
- Summary: 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.

## Related Documents

- [483 - 2020-02-26](https://www.keypedia.com/records/483/msd-international-gmbh-puerto-rico-branch-llc/4cf5af1d-3272-4d14-b1f4-1c3b62f2a5ba)

## Related Officers

- [Jose F. Velez](https://www.keypedia.com/people/jose-f-velez/0d1951e8-3aa5-48ff-bc54-1fae8a7a57c9)
- [investigator](https://www.keypedia.com/people/marian-e-ramirez/4b718b67-fee0-488c-9354-ee366d3510ad)

Company: https://www.keypedia.com/companies/msd-international-gmbh-puerto-rico-branch-llc/98d0fc68-f819-4431-899c-0483c3329777

Office: https://www.keypedia.com/offices/san-juan-district-office/27661cbf-5ba6-4c1b-9b39-4d6df63ca0e8