# FDA 483 - Viatris Pharmaceuticals LLC - May 18, 2026

Source: https://www.keypedia.com/records/483/viatris-pharmaceuticals-llc/14934639-1ca7-4615-a289-4a87365293cb

> FDA 483 for Viatris Pharmaceuticals LLC on May 18, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Viatris Pharmaceuticals LLC
- Inspection Date: 2026-05-18
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: Viatris Pharmaceuticals LLC in Vega Baja, PR, was cited for significant quality control and manufacturing deficiencies. The inspection revealed that drug products were released without adequate nitrosamine impurity testing, and out-of-specification investigations were not thoroughly conducted or accurately reported. Additionally, the facility experienced multiple insect infestations in manufacturing areas, and the firm failed to follow its own procedures for timely completion of investigations and CAPAs.

## Related Documents

- [483 - 2018-01-26](https://www.keypedia.com/records/483/viatris-pharmaceuticals-llc/42243cff-6684-4015-8c0e-a3a388ed6dc4)
- [483 - 2022-02-17](https://www.keypedia.com/records/483/viatris-pharmaceuticals-llc/1f3ad10f-01f0-4d15-bee7-53578d785ba1)

## Related Officers

- [Christian F. Gomez Lugo](https://www.keypedia.com/people/christian-f-gomez-lugo/866e531a-6354-45b2-8e43-1dfc9d146caf)
- [Jose M. Cayuela](https://www.keypedia.com/people/jose-m-cayuela/3ee89bb5-4bba-493b-816f-31b8a9768025)

Company: https://www.keypedia.com/companies/viatris-pharmaceuticals-llc/b3d7bba7-bfc8-4d2b-a517-321f7b518a12

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-iv/a8c8fd15-4e7a-46cb-903a-9980f7ea89e6