# FDA 483 - Eurofins BioPharma Product Testing ENCO Inc. - September 25, 2025

Source: https://www.keypedia.com/records/483/eurofins-biopharma-product-testing-enco-inc/b86532c3-674a-4a60-bf40-50cf95e6892f

> FDA 483 for Eurofins BioPharma Product Testing ENCO Inc. on September 25, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eurofins BioPharma Product Testing ENCO Inc.
- Inspection Date: 2025-09-25
- Product Type: drugs
- Office Name: Florida District Office
- Summary: An FDA inspection of Eurofins BioPharma Product Testing ENCO, LLC in Jacksonville, FL, revealed a significant deficiency in the firm's record-keeping practices. The firm failed to include written records of major equipment use in individual equipment logs, and identified gaps in retrieving these logs through their new eLIMS system. This issue impacts analytical instruments such as HPLC, GC, IC systems, and a Viscometer, indicating a potential data integrity concern.

## Related Officers

- [Oluwasefunmi Agbanigo](https://www.keypedia.com/people/oluwasefunmi-agbanigo/096acae0-9835-4ff1-8faa-c5ec6f551b21)

Company: https://www.keypedia.com/companies/eurofins-biopharma-product-testing-enco-inc/aa1f4107-b323-49a1-ab94-c6ff03e09ad6

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9