Atlas

Form 483

Acclarent, Inc. Form 483, 2013-02-22

FDA issued a Form 483 to Acclarent, Inc. on 2013-02-22 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Acclarent, Inc. · Irvine, United States · Issued February 22, 2013

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.

22 Feb 2013
21 CFR 806.10(a)(1)

Report of risk to health

Cited by Lydia S Chan

22 Feb 2013
21 CFR 820.30(g)

Design validation- Lack of or inadequate procedures

Cited by Lydia S Chan

Inspected site

AIAcclarent, Inc.Irvine, United States

Inspection team

LSLydia S Chan

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 806.10(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 820.30(g)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 observations

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