Atlas

FDA-Inspected Site

All Quality & Services, Inc.

3 FDA inspections are on record for All Quality & Services, Inc. in Fremont, United States.

483· Form 483 issued

Fremont, United States · Last updated August 15, 2026

Overview

  • 3 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-04-10.

At a glance

Inspections

3

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
7 Apr 2026 – 10 Apr 2026Medical Devices & Rad Health483View 483 →
24 Jan 2018 – 1 Feb 2018Medical Devices & Rad Health483View 483 →
8 Apr 2015 – 9 Apr 2015Medical Devices & Rad HealthClean

Observations on record

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

10 Apr 2026
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Brittany D Mccracken, Sasha L Eckstein

10 Apr 2026
ISO 13485:2016 Clause 5.6.1

Management review records not maintained

Cited by Brittany D Mccracken, Sasha L Eckstein

10 Apr 2026
ISO 13485:2016 Clause 6.2

Process(es) for personnel competence, training and awareness not documented

Cited by Brittany D Mccracken, Sasha L Eckstein

10 Apr 2026
ISO 13485:2016 Clause 8.3.1

Procedure for nonconforming product not documented

Cited by Brittany D Mccracken, Sasha L Eckstein

10 Apr 2026
ISO 13485:2016 Clause 8.5.2

Corrective action procedures not documented

Cited by Brittany D Mccracken, Sasha L Eckstein

Investigators

FDA investigators tied to this site in the record.

Brittany D Mccracken1 insp.
Sasha L Eckstein1 insp.
Sara M Richardson1 insp.
Maida Henesian1 insp.
Seema S Singh1 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 820.198(c)Cited across public-safe Form 483 observations3x
21 CFR 820.25(b)Cited across public-safe Form 483 observations3x
21 CFR 820.72(b)Cited across public-safe Form 483 observations3x
21 CFR 820.80(e)Cited across public-safe Form 483 observations3x
21 CFR 803.17Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 5.6.1Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 6.2Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 8.3.1Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 8.5.2Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind All Quality & Services, 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