# FDA 483 - Founders Science Group, LLC - May 17, 2022

Source: https://www.keypedia.com/records/483/founders-science-group-llc/520cf6bc-aff8-4e74-944b-e571a4c31468

> FDA 483 for Founders Science Group, LLC on May 17, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Founders Science Group, LLC
- Inspection Date: 2022-05-17
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: Founders Science Group, LLC, a contract testing laboratory in Taunton, MA, was cited for not establishing and documenting the accuracy, sensitivity, specificity, and reproducibility of its test methods. The firm was found to be unprepared to support the commercial manufacture of a drug product due to a lack of validated analytical methods. This indicates a significant deficiency in their quality control and testing capabilities.

## Related Documents

- [483 - 2019-01-10](https://www.keypedia.com/records/483/founders-science-group-llc/56783ac7-580b-47c4-9d70-88c301399d27)

## Related Officers

- [Senior Consumer Safety Officer - Pharmaceutical Quality](https://www.keypedia.com/people/sean-r-marcsisin/45c910a9-9019-4419-9af8-b1c9f3b1e976)

Company: https://www.keypedia.com/companies/founders-science-group-llc/459e2302-8742-420e-a02a-3adcc1c35d98

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94