# FDA 483 - S and B Pharma LLC DBA Alkem Laboratories - June 17, 2022

Source: https://www.keypedia.com/records/483/s-and-b-pharma-llc-dba-alkem-laboratories/17c696b6-1361-4546-8fd8-8c82fa96f1ec

> FDA 483 for S and B Pharma LLC DBA Alkem Laboratories on June 17, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: S and B Pharma LLC DBA Alkem Laboratories
- Inspection Date: 2022-06-17
- Product Type: drugs
- Office Name: Kansas City District Office
- Summary: An FDA inspection of S and B Pharma LLC DBA Alkem Laboratories in Fenton, MO, revealed significant deficiencies across multiple areas of drug manufacturing. Observations included inadequately designed and qualified capsule filling equipment, a lack of robust written procedures for production and process controls, and insufficient in-process material testing. These findings indicate a need for substantial corrective actions to ensure compliance with cGMP regulations and maintain drug product quality.

## Related Officers

- [Matthew M. Schuckmann](https://www.keypedia.com/people/matthew-m-schuckmann/69dd0728-6b5d-41e7-834c-416e25a977dc)
- [Investigator ](https://www.keypedia.com/people/logan-t-williams/a1febf59-970a-4e4e-9c0c-f4ad385582d7)

Company: https://www.keypedia.com/companies/s-and-b-pharma-llc-dba-alkem-laboratories/e0f542a4-729d-4a3a-8ffa-170135a25aec

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