# FDA 483 - Kashiv BioSciences, LLC - March 12, 2019

Source: https://www.keypedia.com/records/483/kashiv-biosciences-llc/bf815786-aebd-4268-a3e8-ae327e1ebac8

> FDA 483 for Kashiv BioSciences, LLC on March 12, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kashiv BioSciences, LLC
- Inspection Date: 2019-03-12
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: Kashiv BioSciences, LLC in Chicago, IL, received a Form 483 with 7 observations during an inspection from March 4-12, 2019. The inspection revealed significant deficiencies in quality unit procedures, laboratory controls, deviation investigations, and material management. These issues indicate a lack of adherence to established protocols and scientific soundness in testing and storage, impacting the assurance of drug substance and drug product quality and purity.

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## Related Officers

- [Rong Wang, Biologist](https://www.keypedia.com/people/rong-wang-biologist/0998f822-1649-4ba3-88d1-5ff9bbbd4993)
- [Rebecca E. Dombrowski](https://www.keypedia.com/people/rebecca-e-dombrowski/2979b9b1-d067-4165-a5c2-5f0b94dd4eaf)
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- [Steven Fong, Microbiologist](https://www.keypedia.com/people/steven-fong-microbiologist/58ea27ab-f7cd-4680-9253-7460c39911e5)
- [Ramesh Potla, Lead Biologist](https://www.keypedia.com/people/ramesh-potla-lead-biologist/5ae4c8f0-76ca-4f9d-9088-a9eab5c889a0)

Company: https://www.keypedia.com/companies/kashiv-biosciences-llc/4e1d54cb-33c0-4bda-85e8-95cc306e2f33

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321