# FDA 483 - Kashiv BioSciences, LLC - January 14, 2022

Source: https://www.keypedia.com/records/483/kashiv-biosciences-llc/fe8ed97e-6615-4737-a6b3-f5f052694468

> FDA 483 for Kashiv BioSciences, LLC on January 14, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kashiv BioSciences, LLC
- Inspection Date: 2022-01-14
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Kashiv BioSciences, LLC, a drug substance manufacturer in Chicago, Illinois, was cited for multiple deficiencies during an FDA inspection. The observations primarily concern inadequate investigations into environmental monitoring excursions, failure to follow written procedures, and insufficient documentation and data processing controls. These issues indicate significant gaps in quality control and adherence to established manufacturing practices.

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## Related Officers

- [Rong Wang, Biologist](https://www.keypedia.com/people/rong-wang-biologist/0998f822-1649-4ba3-88d1-5ff9bbbd4993)
- [Wendy Tan, PhD, Microbiologist](https://www.keypedia.com/people/wendy-tan-phd-microbiologist/24f63b1c-33e5-440c-9853-2a18c141afa3)
- [Nibin Varghese](https://www.keypedia.com/people/nibin-varghese/43e17f63-2c1f-4d46-b26f-dc8ac8885438)
- [Maria Gutierrez-Hoffman, PhD, Microbiologist](https://www.keypedia.com/people/maria-gutierrez-hoffman-phd-microbiologist/7c26d399-5a57-464b-8a93-9f5e7febae89)
- [Riley Myers, Ph.D.; Lead Biologist](https://www.keypedia.com/people/riley-myers-phd-lead-biologist/f9f7b2db-0820-4e31-95bf-27aa2b6568ea)

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

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd