# FDA 483 - PNEO, LLC - November 05, 2025

Source: https://www.keypedia.com/records/483/pneo-llc/d9a4b72f-5e14-458c-af1e-0708903bc1b9

> FDA 483 for PNEO, LLC on November 05, 2025. Product: devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PNEO, LLC
- Inspection Date: 2025-11-05
- Product Type: devices
- Office Name: Division of Southwest Imports
- Summary: An FDA inspection conducted from November 3 to November 5, 2025, identified significant quality system deficiencies at a manufacturing, complaint file establishment, repackager/relabeler firm located in Denton, TX. The inspection, documented in a Form FDA-483, highlighted three main observations requiring corrective action to ensure compliance with FDA regulations.

Firstly, the firm failed to adequately investigate customer complaints involving potential device failures. A review showed that 64% of complaints lacked documentation regarding product return or root cause analysis, despite internal procedures requiring prompt investigation.

Secondly, the firm's Enterprise Resource Planning (ERP) software, critical to its quality system, had not been adequately validated. The company did not provide documentation demonstrating installation, operational, and performance qualification as required by its own Quality Management System procedure.

Lastly, the inspection revealed inadequate training procedures and implementation. Several employees, including a Team Manager, Logistics Manager, Logistics Support, Director of Marketing, and Office Manager, were not trained according to the firm's training matrix or retrained on updated procedure revisions. These observations indicate a need for the firm to implement comprehensive corrective actions to address its complaint handling, software validation, and employee training systems to meet quality system requirements and prevent future non-compliance.

## Related Documents

- [483 - 2025-11-05](https://www.keypedia.com/records/483/pneo-llc/11a086fa-400a-4206-b8f1-67dfff91058a)

## Related Officers

- [Elizabeth A. Krolczyk](https://www.keypedia.com/people/elizabeth-a-krolczyk/ecf57c43-b88d-4f84-962b-9067eaad4a7c)

Company: https://www.keypedia.com/companies/pneo-llc/24376518-9de6-438b-8b89-54329c09ae01

Office: https://www.keypedia.com/offices/division-of-southwest-imports/1a990c0f-8880-49cd-9fdf-e7e450072e5a