# FDA 483 - Intersect ENT, Inc. - March 06, 2019

Source: https://www.globalkeysolutions.net/records/483/intersect-ent-inc/5e65681e-745f-4153-92b2-3117d177679e

> FDA 483 for Intersect ENT, Inc. on March 06, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Intersect ENT, Inc.
- Inspection Date: 2019-03-06
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Intersect ENT, Inc. in Menlo Park, CA, was cited with four observations during an FDA inspection for deficiencies in quality control, labeling operations, complaint handling, and employee training. The findings indicate a failure to adhere to established standard operating procedures and current good manufacturing practices, potentially impacting product quality and safety.

## Related Documents

- [483 - 2017-11-03](https://www.globalkeysolutions.net/records/483/intersect-ent-inc/9eabbc8a-088f-43ea-8144-020728ec98c7)

## Related Officers

- [Compliance Officer](https://www.globalkeysolutions.net/people/andrew-k-haack/d0e236ac-3223-43e0-8378-300de21b19f5)

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