# FDA 483 - Life Sensing Instruments, Inc. - August 14, 2019

Source: https://www.globalkeysolutions.net/records/483/life-sensing-instruments-inc/6e20cc25-62e7-41b9-adf0-e2595ecca9ac

> FDA 483 for Life Sensing Instruments, Inc. on August 14, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Life Sensing Instruments, Inc.
- Inspection Date: 2019-08-14
- Product Type: device
- Office Name: Atlanta District Office
- Summary: 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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- [483 - 2023-01-27](https://www.globalkeysolutions.net/records/483/life-sensing-instruments-inc/17d85d45-1a6b-4623-a608-7d2d82573f17)

## Related Officers

- [Gamal A. Norton](https://www.globalkeysolutions.net/people/gamal-a-norton/6b52c9e6-d579-4994-81ee-e734eb1f0a67)

Company: https://www.globalkeysolutions.net/companies/life-sensing-instruments-inc/ecbbec3d-b0a9-4744-9658-13cc4b9c9bbf

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7