# FDA 483 - Nelson Laboratories, LLC - September 26, 2025

Source: https://www.globalkeysolutions.net/records/483/nelson-laboratories-llc/ffc3ebd8-900f-4388-839c-9f82593865db

> FDA 483 for Nelson Laboratories, LLC on September 26, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nelson Laboratories, LLC
- Inspection Date: 2025-09-26
- Product Type: other
- Office Name: Chicago District Office
- Summary: Nelson Laboratories, LLC in Itasca, IL, received a Form 483 with four observations during an inspection from September 23-26, 2025. The observations primarily concern significant deficiencies in data integrity practices, including inadequate audit trail verification, non-concurrent data entry, and unmonitored software/hardware failures impacting data generation. Additionally, the firm's stability program for drug products was found to lack proper documentation and control over storage conditions for retained samples.

## Related Officers

- [Bryan L. Mcguckin](https://www.globalkeysolutions.net/people/bryan-l-mcguckin/33eaa16d-a642-4945-81f3-5d9ac180c2db)
- [Angela C. Welker](https://www.globalkeysolutions.net/people/angela-c-welker/b732b19f-c8e8-43b0-bc81-8dcde8a53c84)

Company: https://www.globalkeysolutions.net/companies/nelson-laboratories-llc/56488c12-04e5-4c39-8afb-5411dd826d8e

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669