PNEO, LLCNovember 5, 2025

FDA 483 - PNEO, LLC - November 05, 2025

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Record Details

PNEO, LLC in Denton, TX, received a Form FDA 483 with three observations during an inspection from November 3-5, 2025. The inspection revealed significant deficiencies in complaint handling, software validation for their ERP system, and employee training procedures. These issues indicate a lack of adherence to established quality system requirements.

Company: PNEO, LLC
Inspection Date: November 5, 2025
Product Type: Device
Office: Dallas District Office
Person: Elizabeth A. Krolczyk

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ID · 11a086fa-400a-4206-b8f1-67dfff91058a