# FDA 483 - Viatris Pharmaceuticals LLC - January 26, 2018

Source: https://www.keypedia.com/records/483/viatris-pharmaceuticals-llc/42243cff-6684-4015-8c0e-a3a388ed6dc4

> FDA 483 for Viatris Pharmaceuticals LLC on January 26, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Viatris Pharmaceuticals LLC
- Inspection Date: 2018-01-26
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: Pfizer Pharmaceuticals LLC in Vega Baja, PR, was cited for failing to thoroughly review unexplained discrepancies during an inspection from January 10-26, 2018. Specifically, the firm did not adequately investigate critical defects like broken Nitrostat tablets in distributed lots. The investigation was incomplete, as it failed to evaluate manufacturing process parameters and lacked proper user permission controls for critical system parameters.

## Related Documents

- [483 - 2022-02-17](https://www.keypedia.com/records/483/viatris-pharmaceuticals-llc/1f3ad10f-01f0-4d15-bee7-53578d785ba1)

## 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/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