FDA Inspection
Intersect ENT, Inc.Intersect ENT, Inc. – FDA Inspection, Nov 3, 2017
Record Details
This FDA Inspection record concerns Intersect ENT, Inc., with an inspection on November 3, 2017, issued by the San Francisco District Office, covering human drugs.
- People
- Chengjiu Hu (Issuing Officer)
- Lucila B. Nwatu (FDA Associated Person)
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ID · 7aa084f2-49b8-4d49-a997-31e51bf7de64
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1030747
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.68(b)Computer control of master formula records
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Other FDA inspections of Intersect ENT, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 7, 2025 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 6, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 6, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 27, 2014 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| December 11, 2012 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Intersect ENT, Inc.
- FDA Inspection 1282446 - 2025-08-07
- FDA Inspection 1082757 - 2019-03-06
- FDA Inspection 1009402 - 2017-04-06
- FDA Inspection 883393 - 2014-06-27
- FDA Inspection 809111 - 2012-12-11
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