Atlas

FDA-Inspected Site

Comfortland Medical, Inc.

2 FDA inspections are on record for Comfortland Medical, Inc. in Mebane, United States.

483· Form 483 issued

Mebane, United States · Last updated July 10, 2026

Overview

  • 2 FDA inspections are on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2026-06-12.

At a glance

Inspections

2

Form 483s

1

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
10 Jun 2026 – 12 Jun 2026Medical Devices & Rad Health483View 483 →
26 Sep 2016Medical Devices & Rad HealthClean

Observations on record

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

12 Jun 2026
21 CFR 801.20(a)

Label to bear a unique device identifier

Cited by Christopher B May

12 Jun 2026
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Christopher B May

12 Jun 2026
ISO 13485:2016 Clause 4.1.1

QMS not documented and maintained adequately

Cited by Christopher B May

12 Jun 2026
ISO 13485:2016 Clause 4.1.5

Control over outsourced processes not proportionate to risk

Cited by Christopher B May

12 Jun 2026
ISO 13485:2016 Clause 7.1

Processes needed for product realization not planned and developed

Cited by Christopher B May

Investigators

FDA investigators tied to this site in the record.

Christopher B May1 insp.
Heather M Roach1 insp.
Heather M Wheeler1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 801.20(a)Cited across public-safe Form 483 observations1x
21 CFR 803.17Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 4.1.1Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 4.1.5Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.1Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.3.10Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.5.1Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 8.2.2Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Comfortland Medical, Inc.'s 1 Form 483

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