# FDA 483 - Kashiv BioSciences, LLC - November 21, 2107

Source: https://www.globalkeysolutions.net/records/483/kashiv-biosciences-llc/8a5d2e48-7ff7-4823-a90e-0bf271b2cb62

> FDA 483 for Kashiv BioSciences, LLC on November 21, 2107. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kashiv BioSciences, LLC
- Inspection Date: 2107-11-21
- Product Type: drugs
- Office Name: Division of Advertising & Promotion 
- Summary: An FDA inspection of Adello Biologics, LLC in Chicago, IL, a drug substance and drug product manufacturing facility, revealed significant deficiencies in quality oversight, laboratory procedures, and deviation investigations. The firm also failed to adequately control critical materials after temperature excursions and did not consistently follow written procedures for logbook management and validation. Inadequate written procedures for pest control were also noted.

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## Related Officers

- [Brian D. Nicholson](https://www.globalkeysolutions.net/people/brian-d-nicholson/83ea13dd-6753-468a-a0ca-19e3ef4158dd)
- [investigator](https://www.globalkeysolutions.net/people/merry-christie/e179515c-d9b2-4f06-ac2e-1f4be89b63c9)
- [Diane Raccasi](https://www.globalkeysolutions.net/people/diane-raccasi/5c51bbf4-9c91-49c5-a1a5-d5aa7374890b)
- [investigator](https://www.globalkeysolutions.net/people/tracy-denison/2690d043-2209-4437-999c-634af9ae63cc)
- [investigator](https://www.globalkeysolutions.net/people/kathleen-r-jones/3760ffcd-ce90-4b7c-b0a6-726edc8264d8)

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

Office: https://www.globalkeysolutions.net/offices/division-of-advertising-promotion/adcc8282-aca9-4610-955c-e6553c7619b0