Atlas

Form 483

Intersect ENT, Inc. Form 483, 2012-12-11

FDA issued a Form 483 to Intersect ENT, Inc. on 2012-12-11 with 2 public-safe observations.

483· Form 483 issued2 observations

Intersect ENT, Inc. · Menlo Park, United States · Issued December 11, 2012

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

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

Report of Death or Serious Injury

Cited by Mary R Hole

11 Dec 2012
21 CFR 820.198(c)

Investigation of device failures

Cited by Mary R Hole

Inspected site

IEIntersect ENT, Inc.Menlo Park, United States

Inspection team

MRMary R Hole

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.50(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 820.198(c)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Book a demoStart a free trial

Full 483 report

Get the verbatim text of all 2 observations

The source PDF and every observation in full, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere