# FDA 483 - Bausch Health Americas, Inc. - April 12, 2024

Source: https://www.keypedia.com/records/483/bausch-health-americas-inc/0405b6f6-ed37-409c-ab46-0eaaeb6d382e

> FDA 483 for Bausch Health Americas, Inc. on April 12, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bausch Health Americas, Inc.
- Inspection Date: 2024-04-12
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Bausch Health Americas, Inc. in Petaluma, CA, a control testing laboratory, was cited for significant deficiencies in its Quality Control Unit's responsibilities and procedures. The inspection revealed failures to initiate investigations for audit trail deviations and equipment malfunctions, a lack of annual product reviews, and inadequate oversight of laboratory investigations and documentation. These issues indicate a systemic breakdown in quality assurance processes.

## Related Officers

- [Navneet Kaur](https://www.keypedia.com/people/navneet-kaur/23db67cc-7589-46f9-bbb9-930c0460500f)
- [Claudia M. Perez-Kasmarski](https://www.keypedia.com/people/claudia-m-perez-kasmarski/ee989ba2-eb7a-47ae-8be5-7a28f748343b)

Company: https://www.keypedia.com/companies/bausch-health-americas-inc/46368cf4-fd1b-4ed0-a010-ae5ccd022cb6

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b