# FDA 483 - Viatris Pharmaceuticals LLC - December 20, 2019

Source: https://www.globalkeysolutions.net/records/483/viatris-pharmaceuticals-llc/00fdf6d6-dc92-452b-a9c1-56e9f8d35318

> FDA 483 for Viatris Pharmaceuticals LLC on December 20, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Viatris Pharmaceuticals LLC
- Inspection Date: 2019-12-20
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: This FDA Form 483 was issued to PFIZER PHARMACEUTICALS LLC in Barceloneta, Puerto Rico, a manufacturer of API and drug products. The inspection revealed significant deficiencies in the quality control unit's investigation processes, ineffective implementation of corrective and preventive actions, and incomplete batch production and control records. These observations indicate a lack of adherence to established procedures and proper documentation practices.

## Related Documents

- [483 - 2013-08-20](https://www.globalkeysolutions.net/records/483/viatris-pharmaceuticals-llc/352f1119-f6b0-4110-8fe4-6b9ce406ca1c)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/noreen-muniz/0bb20d12-62ad-42aa-8b0a-c44b339d413f)

Company: https://www.globalkeysolutions.net/companies/viatris-pharmaceuticals-llc/86ee0564-73c3-4575-acbc-56fb8e87627c

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