FDA-Inspected Site

Memtec Corporation

7 FDA inspections are on record for Memtec Corporation in Salem, United States.

Clean· No action indicated

Salem, United States · Last updated July 10, 2026

Overview

  • 7 FDA inspections are on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2021-08-06.

At a glance

Inspections

7

Form 483s

1

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
6 Aug 2021Medical Devices & Rad HealthClean
1 Feb 2019 – 4 Feb 2019Medical Devices & Rad Health483View 483 →
19 Nov 2015 – 20 Nov 2015Medical Devices & Rad HealthClean
6 Nov 2013Medical Devices & Rad HealthClean
31 Oct 2011Not recordedClean
26 Mar 2009Not recordedClean
14 May 2003Not recordedClean

Observations on record

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

4 Feb 2019
21 CFR 803.17

Lack of Written MDR Procedures

Cited by James W Whitney

4 Feb 2019
21 CFR 803.17

Lack of Written MDR Procedures

Cited by James W Whitney

4 Feb 2019
21 CFR 820.184

DHR - not or inadequately maintained

Cited by James W Whitney

4 Feb 2019
21 CFR 820.184

DHR - not or inadequately maintained

Cited by James W Whitney

4 Feb 2019
21 CFR 820.50(b)

Supplier notification of changes

Cited by James W Whitney

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.184Cited across public-safe Form 483 observations4x
21 CFR 803.17Cited across public-safe Form 483 observations2x
21 CFR 820.50(b)Cited across public-safe Form 483 observations2x

Full site report

Get the verbatim findings behind Memtec Corporation's 1 Form 483

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