# FDA 483 - Immunologix Laboratories - September 12, 2025

Source: https://www.keypedia.com/records/483/immunologix-laboratories/de680405-0e1a-424b-a14f-fae2baa266cc

> FDA 483 for Immunologix Laboratories on September 12, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Immunologix Laboratories
- Inspection Date: 2025-09-12
- Product Type: other
- Office Name: Florida District Office
- Summary: An FDA inspection of Immunologix Laboratories in Tampa, FL, a nonclinical laboratory, identified one observation. The primary concern was the failure of the study director to ensure proper archiving of raw data and documentation for bioanalytical studies. This indicates a significant issue with data integrity and record-keeping practices.

## Related Officers

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Company: https://www.keypedia.com/companies/immunologix-laboratories/6636ec26-96f9-4aaa-811d-84292e83aad1

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