Atlas

FDA-Inspected Site

Intersect ENT, Inc.

8 FDA inspections are on record for Intersect ENT, Inc. in Menlo Park, United States.

Clean· No action indicated

Menlo Park, United States · Last updated July 9, 2026

Overview

  • 8 FDA inspections are on record.
  • 4 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-08-07.

At a glance

Inspections

8

Form 483s

4

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
4 Aug 2025 – 7 Aug 2025Human DrugsClean
27 Feb 2019 – 6 Mar 2019Human Drugs483On file
30 Oct 2017 – 3 Nov 2017Human Drugs483View 483 →
4 Apr 2017 – 6 Apr 2017Medical Devices & Rad HealthClean
23 Jun 2014 – 27 Jun 2014Medical Devices & Rad HealthClean
25 Mar 2013 – 27 Mar 2013Medical Devices & Rad HealthClean
11 Dec 2012Not recorded483View 483 →
9 May 2011Not recorded483View 483 →

Observations on record

Form 483 observations cited at this site, most recent first.

3 Nov 2017
21 CFR 211.110(a)

Control procedures to monitor and validate performance

Cited by Lucila B Nwatu, Chengjiu Hu

3 Nov 2017
21 CFR 211.188(b)

Batch production and Batch Control Record Requirements

Cited by Lucila B Nwatu, Chengjiu Hu

3 Nov 2017
21 CFR 211.25(a)

Training , Education , Experience overall

Cited by Lucila B Nwatu, Chengjiu Hu

3 Nov 2017
21 CFR 211.68(b)

Computer control of master formula records

Cited by Lucila B Nwatu, Chengjiu Hu

11 Dec 2012
21 CFR 803.50(a)(1)

Report of Death or Serious Injury

Cited by Mary R Hole

Investigators

FDA investigators tied to this site in the record.

Joey V Quitania1 insp.
Gunneet Kaur1 insp.
Anney Lin1 insp.
Andrew K Haack1 insp.
Lucila B Nwatu1 insp.
Chengjiu Hu1 insp.
James A Lane1 insp.
Jude C Dike1 insp.
Joseph A Seitz1 insp.
Mary R Hole1 insp.
Lydia S Chan1 insp.
William V Millar1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.110(a)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.188(b)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.68(b)Cited across public-safe Form 483 observations1x
21 CFR 803.50(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.198(c)Cited across public-safe Form 483 observations1x
21 CFR 820.50Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Intersect ENT, Inc.'s 4 Form 483s

Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat