Life Sensing Instruments, Inc.January 27, 2023

FDA 483 - Life Sensing Instruments, Inc. - January 27, 2023

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Record Details

An FDA inspection of Life Sensing Instruments, Inc. in Charlotte, NC, from January 23-27, 2023, revealed a significant quality system deficiency. The firm failed to adequately establish and follow procedures for ensuring that purchased products and services conform to specified requirements, specifically regarding supplier evaluations. This indicates a breakdown in their purchasing controls and documentation practices.

Company: Life Sensing Instruments, Inc.
Inspection Date: January 27, 2023
Product Type: Device
Office: Division of Human and Animal Food Operations - East IV
Person: Nydia E. Colon

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ID · 17d85d45-1a6b-4623-a608-7d2d82573f17