Atlas

FDA-Inspected Site

Sauna Works, Inc

1 FDA inspection is on record for Sauna Works, Inc in Berkeley, United States.

483· Form 483 issued

Berkeley, United States · Last updated July 12, 2026

Overview

  • 1 FDA inspection is on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2025-12-10.

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
2 Dec 2025 – 10 Dec 2025Medical Devices & Rad Health483View 483 →

Observations on record

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

10 Dec 2025
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Bryce A May, Nga T Ho, Richard E Evoy

10 Dec 2025
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Bryce A May, Nga T Ho, Richard E Evoy

10 Dec 2025
21 CFR 820.120

Lack of or inadequate procedures for labeling

Cited by Bryce A May, Nga T Ho, Richard E Evoy

10 Dec 2025
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Bryce A May, Nga T Ho, Richard E Evoy

10 Dec 2025
21 CFR 820.20(c)

Management review - Lack of or inadequate procedures

Cited by Bryce A May, Nga T Ho, Richard E Evoy

Investigators

FDA investigators tied to this site in the record.

Bryce A May1 insp.
Nga T Ho1 insp.
Richard E Evoy1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 803.17Cited across public-safe Form 483 observations1x
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.120Cited across public-safe Form 483 observations1x
21 CFR 820.198(a)Cited across public-safe Form 483 observations1x
21 CFR 820.20(c)Cited across public-safe Form 483 observations1x
21 CFR 820.22Cited across public-safe Form 483 observations1x
21 CFR 820.30(a)Cited across public-safe Form 483 observations1x
21 CFR 820.50Cited across public-safe Form 483 observations1x
21 CFR 820.80(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Sauna Works, 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