# FDA 483 - S&B Pharma LLC - February 06, 2020

Source: https://www.keypedia.com/records/483/sb-pharma-llc/7c8eca03-a9d6-4627-9021-7dda9ea19576

> FDA 483 for S&B Pharma LLC on February 06, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: S&B Pharma LLC
- Inspection Date: 2020-02-06
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of S & B Pharma, Inc. dba Alkem Laboratories in Fenton, MO, a drug manufacturer, revealed significant deficiencies in quality control and record-keeping. Observations included inadequate investigation records and corrective actions, scientifically unsound laboratory sampling plans, and a failure to conduct required annual product reviews. These issues indicate a lack of adherence to good manufacturing practices.

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## Related Officers

- [Victoria Quadrini](https://www.keypedia.com/people/victoria-quadrini/4b0e8309-2067-483e-a792-1a3e321f87ea)
- [Matthew M. Schuckmann](https://www.keypedia.com/people/matthew-m-schuckmann/69dd0728-6b5d-41e7-834c-416e25a977dc)
- [Investigator?](https://www.keypedia.com/people/robert-j-ham/9146e819-4fce-420c-a722-cbe14e3c6afb)
- [issuing_officer](https://www.keypedia.com/people/sri-rama-krishnaiah-yellela/9cf2e148-03b3-4e6a-b878-6dee15f651a6)

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