# FDA 483 - BioChem Sioux City Inc. - August 06, 2021

Source: https://www.globalkeysolutions.net/records/483/biochem-sioux-city-inc/8cacec91-83aa-4431-af3e-1594777bb0cd

> FDA 483 for BioChem Sioux City Inc. on August 06, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BioChem Sioux City Inc.
- Inspection Date: 2021-08-06
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Aspen API, Inc. in Sioux City, Iowa, was inspected regarding its crude heparin manufacturing, revealing significant issues with contamination control and product quality. The firm failed to adequately protect Crude Heparin Sodium from contamination and allowed untrained employees to overrule critical product release decisions. Additionally, the inspection found deficiencies in testing procedures and the accuracy of Certificates of Analysis.

## Related Officers

- [Matthew M. Schuckmann](https://www.globalkeysolutions.net/people/matthew-m-schuckmann/69dd0728-6b5d-41e7-834c-416e25a977dc)
- [ Investigator ](https://www.globalkeysolutions.net/people/matthew-b-casale/e78481c6-5fbd-4723-a79c-167176395af8)

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

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8