# FDA 483 - S&B Pharma LLC - November 08, 2022

Source: https://www.keypedia.com/records/483/sb-pharma-llc/cbd2778e-6463-41d5-b971-7ba37d3963f7

> FDA 483 for S&B Pharma LLC on November 08, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: S&B Pharma LLC
- Inspection Date: 2022-11-08
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: S and B Pharma, Inc. in Fenton, MO, a drug manufacturer, was cited for significant deficiencies during an FDA inspection. Observations included failures in thoroughly investigating out-of-specification results and production deviations, inadequate quality control unit procedures for data review and batch release, and a lack of established procedures for testing drug products for objectionable microorganisms like Burkholderia cepacia complex. These issues indicate a need for improved quality system oversight and microbial control.

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- [483 - 2022-09-14](https://www.keypedia.com/records/483/sb-pharma-llc/6921b8c4-de76-4aad-be9e-2cd352638bf5)

## Related Officers

- [Monica E. Murie](https://www.keypedia.com/people/monica-e-murie/2db840df-d69f-4def-9830-fd461bea5507)
- [Regulatory Officer ](https://www.keypedia.com/people/jill-tillman/4fd81eed-0de2-468b-a776-d4809fa91553)
- [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/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8