# FDA 483 - Kashiv BioSciences, LLC - January 22, 2018

Source: https://www.globalkeysolutions.net/records/483/kashiv-biosciences-llc/5d273094-8fb3-48f0-b81c-e42aaced51fd

> FDA 483 for Kashiv BioSciences, LLC on January 22, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kashiv BioSciences, LLC
- Inspection Date: 2018-01-22
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: Adello Biologics LLC, a drug substance and drug product manufacturing facility in Chicago, IL, was cited for significant data integrity and quality control issues during an FDA inspection. Observations included failures in ensuring scientifically sound test procedures, inadequate review of analytical data, insufficient controls to prevent data manipulation, and poor control over GMP documents. These findings indicate a systemic lack of robust quality systems.

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## Related Officers

- [Mercy Christie, Chemist](https://www.globalkeysolutions.net/people/mercy-christie-chemist/e2a4474b-8f95-4d4d-912d-8b8081f58474)
- [Justin A. Boyd, Investigator](https://www.globalkeysolutions.net/people/justin-a-boyd-investigator/db1000e7-021c-4af3-b45d-8b5d4eefe925)
- [Compliance Officer at FDA](https://www.globalkeysolutions.net/people/christopher-d-leach/2a3c4b73-f082-4f33-aa2d-52d1abbb6d55)

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

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669