Company
United StatesIntersect ENT, Inc., Menlo Park, CA – FDA Inspections
Inspection records and compliance data for Intersect ENT, Inc. in Menlo Park, California. 7 FDA inspections on record, 2 Form 483s, last inspected August 07, 2025.
Company Profile
This profile covers Intersect ENT, Inc. based in Menlo Park, California, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 4
- NAI
- 3
- Form 483s
- 2
- Warning letters
- 0
First inspected May 9, 2011. Last inspected August 7, 2025.
Most cited issue areas
- Batch production and Batch Control Record Requirements1 inspection
- Computer control of master formula records1 inspection
- Control procedures to monitor and validate performance1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 7, 2025 | NAI | Human Drugs · Drug Quality Assurance | 1282446 |
| March 6, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1082757 |
| November 3, 2017 | VAI | Human Drugs · New Drug Evaluation | 1030747 |
| April 6, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1009402 |
| June 27, 2014 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 883393 |
| December 11, 2012 | VAI | Human Drugs, Medical Devices & Rad Health · Bioresearch Monitoring | 809111 |
| May 9, 2011 | VAI | Human Drugs · Drug Quality Assurance | 723564 |
FDA documents
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Company Information
Name
Intersect ENT, Inc.
FEI Number
3008301917
Address
1555 Adams Dr, Menlo Park, California 94025, United States
Country
United States
ID: 4b6941c3-1d67-4c6e-8f2b-febe75f3f7dc