# FDA 483 - Huber Soda, LLC - December 06, 2024

Source: https://www.keypedia.com/records/483/huber-soda-llc/ee3672b4-7c0a-43af-b373-c9aebe4c4a37

> FDA 483 for Huber Soda, LLC on December 06, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Huber Soda, LLC
- Inspection Date: 2024-12-06
- Product Type: drugs
- Office Name: New York District Office
- Summary: An FDA inspection of Huber Soda, LLC in Cortland, NY, an API manufacturer, revealed significant deficiencies across multiple areas. Observations included inadequate process validation for Sodium Bicarbonate, an unsuitable water system, uncontrolled storage conditions for finished products, and a failure to address persistent poor documentation practices in batch records. These issues collectively indicate a lack of control over critical manufacturing processes and data integrity, potentially impacting product quality.

## Related Officers

- [Christian F. Gomez Lugo](https://www.keypedia.com/people/christian-f-gomez-lugo/866e531a-6354-45b2-8e43-1dfc9d146caf)
- [Tanya R. Syffrard](https://www.keypedia.com/people/tanya-r-syffrard/a78a42b3-6cef-46d9-9698-ec6082956477)
- [investigator](https://www.keypedia.com/people/divek-r-jumani/ba9b28e9-d9b3-4c9f-8532-25f037ff7ce4)

Company: https://www.keypedia.com/companies/huber-soda-llc/89d2a595-ba2c-46a2-987c-65bb21b1b75b

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d