# FDA 483 - S&B Pharma LLC - June 18, 2021

Source: https://www.keypedia.com/records/483/sb-pharma-llc/3f2bce60-dc5e-4393-a563-4b89149f6f9c

> FDA 483 for S&B Pharma LLC on June 18, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: S&B Pharma LLC
- Inspection Date: 2021-06-18
- Product Type: drugs
- Office Name: Kansas City District Office
- Summary: An FDA inspection of S & B Pharma, Inc. dba Alkem Laboratories in Fenton, MO, a human drug manufacturer, revealed significant deficiencies in equipment design and qualification, as well as the quality control unit's procedures. The firm failed to ensure manufacturing equipment was in a qualified state and lacked proper documentation and scientific justification for critical quality attributes and testing. These findings indicate serious concerns regarding the firm's adherence to good manufacturing practices for drug products.

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## Related Officers

- [Vikas Moolchandani, Chemist](https://www.keypedia.com/people/vikas-moolchandani-chemist/1d090040-feac-43de-83bd-40d6c6536225)
- [Matthew M. Schuckmann](https://www.keypedia.com/people/matthew-m-schuckmann/69dd0728-6b5d-41e7-834c-416e25a977dc)
- [DeMonna M. Epps, CSO](https://www.keypedia.com/people/demonna-m-epps-cso/86f252e9-ddb5-4a15-a680-87d905cace4c)
- [Investigator?](https://www.keypedia.com/people/robert-j-ham/9146e819-4fce-420c-a722-cbe14e3c6afb)

Company: https://www.keypedia.com/companies/sb-pharma-llc/232b2ea9-4ea7-41e2-aed7-7b885ca80003

Office: https://www.keypedia.com/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79