# FDA 483 - BioChem Sioux City Inc. - March 19, 2026

Source: https://www.keypedia.com/records/483/biochem-sioux-city-inc/4dcadc7f-060b-498f-a2cc-407a34ad2248

> FDA 483 for BioChem Sioux City Inc. on March 19, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BioChem Sioux City Inc.
- Inspection Date: 2026-03-19
- Product Type: drugs
- Office Name: Kansas City District Office
- Summary: BioChem Sioux City, Inc. in Sioux City, IA, was cited with two observations during an FDA inspection of its heparin sodium crude manufacturing operations. The firm failed to establish an ongoing stability program for heparin sodium crude to support its assigned expiration date. Additionally, the company has been using a modified heparin sodium assay method for 15-20 years without proper validation.

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- [483 - 2021-08-06](https://www.keypedia.com/records/483/biochem-sioux-city-inc/8cacec91-83aa-4431-af3e-1594777bb0cd)
- [483 - 2026-03-19](https://www.keypedia.com/records/483/biochem-sioux-city-inc/bcf355fd-062e-4f5b-8285-d8af20329648)

## Related Officers

- [Carolina D. Vasquez](https://www.keypedia.com/people/carolina-d-vasquez/ffa9d542-e660-4575-831e-f11a2de4b978)

Company: https://www.keypedia.com/companies/biochem-sioux-city-inc/5ce2b95e-6c89-4fb9-bbb4-210bd8272365

Office: https://www.keypedia.com/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79