# FDA 483 - Intersect ENT, Inc. - November 03, 2017

Source: https://www.globalkeysolutions.net/records/483/intersect-ent-inc/9eabbc8a-088f-43ea-8144-020728ec98c7

> FDA 483 for Intersect ENT, Inc. on November 03, 2017. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Intersect ENT, Inc.
- Inspection Date: 2017-11-03
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of Intersect ENT, Inc. in Menlo Park, CA, a sterile finished drug-device combination product manufacturer, revealed significant deficiencies. Observations included inadequate validation of manufacturing processes and computer systems, incomplete batch production records, and insufficient employee training for visual inspections. These issues indicate a lack of robust quality control and compliance with regulatory requirements.

## Related Documents

- [483 - 2019-03-06](https://www.globalkeysolutions.net/records/483/intersect-ent-inc/5e65681e-745f-4153-92b2-3117d177679e)

## Related Officers

- [Chenlu He](https://www.globalkeysolutions.net/people/chenlu-he/cc316e10-1a7c-4b4a-8e7d-2b52dee3e556)
- [National Program Expert- Pharmacy Compounding](https://www.globalkeysolutions.net/people/lucila-b-nwatu/3d1c9670-8206-425c-bddd-32e395293042)

Company: https://www.globalkeysolutions.net/companies/intersect-ent-inc/4b6941c3-1d67-4c6e-8f2b-febe75f3f7dc

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b