# FDA 483 - S & B Pharma LLC - August 22, 2019

Source: https://www.globalkeysolutions.net/records/483/s-b-pharma-llc/695be28d-a9c2-4c15-a67a-08bba338eab7

> FDA 483 for S & B Pharma LLC on August 22, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: S & B Pharma LLC
- Inspection Date: 2019-08-22
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: S and B Pharma, Inc. dba Alkem Laboratories in Fenton, MO, a drug manufacturer, was cited with four observations during an FDA inspection. The inspection revealed significant deficiencies in warehousing procedures, documentation practices for production and process controls, complaint handling, and facility maintenance. These issues indicate a lack of adherence to established procedures and good manufacturing practices.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/michele-perry-williams/80741e95-8df3-41c9-b9b8-499fcb97921d)

Company: https://www.globalkeysolutions.net/companies/s-b-pharma-llc/1b2c35eb-eb40-4a46-8608-2b5d940d0b61

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8