Atlas

FDA-Inspected Site

Smart World LLC

6 FDA inspections are on record for Smart World LLC in Fremont, United States.

483· Form 483 issued

Fremont, United States · Last updated August 15, 2026

Overview

  • 6 FDA inspections are on record.
  • 4 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-06-05.

At a glance

Inspections

6

Form 483s

4

EIRs

2

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
1 Jun 2026 – 5 Jun 2026Medical Devices & Rad Health483View 483 →
29 May 2025 – 3 Jun 2025Human Drugs483View 483 →
12 Sep 2022 – 15 Sep 2022BiologicsClean
5 Mar 2020 – 10 Mar 2020Medical Devices & Rad HealthClean
8 Apr 2019 – 10 Apr 2019Human Drugs483View 483 →
15 Aug 2017 – 22 Aug 2017Medical Devices & Rad Health483View 483 →

Observations on record

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

5 Jun 2026
ISO 13485:2016 Clause 7.1

Product realization risk management processes not documented

Cited by Jordan I Abel, Sasha L Eckstein

5 Jun 2026
ISO 13485:2016 Clause 7.2.1

Requirements related to product not determined

Cited by Jordan I Abel, Sasha L Eckstein

3 Jun 2025
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Cecilia H Kieu

3 Jun 2025
21 CFR 211.58

Buildings not maintained in good state of repair

Cited by Cecilia H Kieu

10 Apr 2019
21 CFR 211.100(b)

Procedure Deviations Recorded and Justified

Cited by Zachary A Bogorad

Investigators

FDA investigators tied to this site in the record.

Jordan I Abel1 insp.
Sasha L Eckstein1 insp.
Cecilia H Kieu1 insp.
Karen J Bak1 insp.
Maida Henesian1 insp.
Zachary A Bogorad1 insp.
Quynh Strandberg1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations2x
21 CFR 820.186Cited across public-safe Form 483 observations2x
21 CFR 820.198(a)Cited across public-safe Form 483 observations2x
21 CFR 820.72(a)Cited across public-safe Form 483 observations2x
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.58Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.1Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.2.1Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Smart World LLC's 4 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