Atlas

FDA-Inspected Site

MANSBACH HEALTH TOOLS LLC

1 FDA inspection is on record for MANSBACH HEALTH TOOLS LLC in Potomac, United States.

483· Form 483 issued

Potomac, United States · Last updated August 15, 2026

Overview

  • 1 FDA inspection is on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2026-06-02.

At a glance

Inspections

1

Form 483s

1

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
22 May 2026 – 2 Jun 2026Medical Devices & Rad Health483View 483 →

Observations on record

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

2 Jun 2026
21 CFR 830.300(a)

Devices subject to device identification GUDID data submission requirements.

Cited by Christina D Mello

2 Jun 2026
ISO 13485:2016 Clause 4.1.2

Risk-based approach not applied to QMS processes

Cited by Christina D Mello

2 Jun 2026
ISO 13485:2016 Clause 5.6.2

Input to management review is incomplete

Cited by Christina D Mello

2 Jun 2026
ISO 13485:2016 Clause 7.1

Required elements not determined in planning product realization

Cited by Christina D Mello

2 Jun 2026
ISO 13485:2016 Clause 7.3.10

Design and development files not maintained

Cited by Christina D Mello

Investigators

FDA investigators tied to this site in the record.

Christina D Mello1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 830.300(a)Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 4.1.2Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 5.6.2Cited 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 7.3.7Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.4.1Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.5.1Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.5.6Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 8.2.1Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 8.2.4Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind MANSBACH HEALTH TOOLS LLC'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