# FDA 483 - Next Science, LLC - October 25, 2019

Source: https://www.keypedia.com/records/483/next-science-llc/ca852c3a-16cb-4384-9bf0-41f28c45e921

> FDA 483 for Next Science, LLC on October 25, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Next Science, LLC
- Inspection Date: 2019-10-25
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Next Science Manufacturing in Jacksonville, FL, revealed significant deficiencies in their drug product manufacturing operations. The firm failed to maintain adequate complaint handling procedures, lacked sufficient stability data to support drug product expiration dates, and did not validate key manufacturing processes. These issues indicate a broad non-compliance with good manufacturing practices, raising concerns about product quality and safety.

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## Related Officers

- [Susan O. Oladeji](https://www.keypedia.com/people/susan-o-oladeji/307277f8-7704-4ada-8d8d-d77118c6cb77)

Company: https://www.keypedia.com/companies/next-science-llc/85588e89-3b46-46a8-9278-095498239b60

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7