483
Life Sensing Instruments, Inc.FDA 483 - Life Sensing Instruments, Inc. - August 14, 2019
Record Details
An FDA inspection of Eite Sensing Instruments, Inc. in Charlotte, NC, revealed significant deficiencies in their quality system for device manufacturing. The firm was cited for multiple issues including inadequate design validation, insufficient documentation in design history files, and unvalidated manufacturing processes. These observations indicate a need for comprehensive corrective actions to ensure compliance with regulatory requirements.
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ID · 6e20cc25-62e7-41b9-adf0-e2595ecca9ac