Atlas

FDA-Inspected Site

Kentec Medical, Inc

5 FDA inspections are on record for Kentec Medical, Inc in Irvine, United States.

483· Form 483 issued

Irvine, United States · Last updated July 10, 2026

Overview

  • 5 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2018-07-30.

At a glance

Inspections

5

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
26 Jul 2018 – 30 Jul 2018Medical Devices & Rad Health483View 483 →
6 May 2015 – 11 May 2015Medical Devices & Rad HealthClean
19 Sep 2014 – 24 Sep 2014Medical Devices & Rad HealthClean
19 Oct 2012Not recordedClean
16 Dec 2009Not recorded483View 483 →

Observations on record

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

30 Jul 2018
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Joshua J Silvestri

30 Jul 2018
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Joshua J Silvestri

30 Jul 2018
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Joshua J Silvestri

30 Jul 2018
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Joshua J Silvestri

30 Jul 2018
21 CFR 820.30(e)

Design review - Lack of or inadequate procedures

Cited by Joshua J Silvestri

Investigators

FDA investigators tied to this site in the record.

Angela Shepas2 insp.
Joshua J Silvestri1 insp.
Vickie L Anderson1 insp.
Laverne Kimble1 insp.
Mei-Chen Mu1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 803.17Cited across public-safe Form 483 observations2x
21 CFR 820.100(a)Cited across public-safe Form 483 observations2x
21 CFR 820.30(e)Cited across public-safe Form 483 observations2x
21 CFR 820.30(f)Cited across public-safe Form 483 observations2x
21 CFR 820.30(g)Cited across public-safe Form 483 observations2x
21 CFR 820.50Cited across public-safe Form 483 observations2x
21 CFR 820.30(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Kentec Medical, Inc's 2 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