Atlas

FDA-Inspected Site

Tripath Imaging, Inc.

5 FDA inspections are on record for Tripath Imaging, Inc. in Burlington, United States.

483· Form 483 issued

Burlington, United States · Last updated July 10, 2026

Overview

  • 5 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2017-01-10.

At a glance

Inspections

5

Form 483s

3

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
5 Dec 2016 – 10 Jan 2017Medical Devices & Rad Health483View 483 →
18 Aug 2014 – 29 Aug 2014Medical Devices & Rad Health483On file
5 Sep 2008Not recorded483On file
22 Aug 2003Not recordedClean
25 Sep 2002Not recordedClean

Observations on record

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

10 Jan 2017
21 CFR 820.100(b)

Documentation

Cited by Claudette D Brooks, Christopher B May

10 Jan 2017
21 CFR 820.150

Lack of or inadequate procedures for storage.

Cited by Claudette D Brooks, Christopher B May

10 Jan 2017
21 CFR 820.22

Quality Audits - defined intervals

Cited by Claudette D Brooks, Christopher B May

10 Jan 2017
21 CFR 820.30(f)

Design verification - documentation

Cited by Claudette D Brooks, Christopher B May

10 Jan 2017
21 CFR 820.30(g)

Design validation - documentation

Cited by Claudette D Brooks, Christopher B May

Investigators

FDA investigators tied to this site in the record.

Claudette D Brooks3 insp.
Christopher B May1 insp.
Brenda Rivera1 insp.
Myoshi M Francis1 insp.
John A Casanova1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.100(b)Cited across public-safe Form 483 observations3x
21 CFR 820.150Cited across public-safe Form 483 observations3x
21 CFR 820.22Cited across public-safe Form 483 observations3x
21 CFR 820.30(f)Cited across public-safe Form 483 observations3x
21 CFR 820.30(g)Cited across public-safe Form 483 observations3x
21 CFR 820.72(a)Cited across public-safe Form 483 observations3x
21 CFR 820.75(c)Cited across public-safe Form 483 observations3x
21 CFR 820.90(a)Cited across public-safe Form 483 observations3x

Full site report

Get the verbatim findings behind Tripath Imaging, Inc.'s 3 Form 483s

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