Sauna Works, Inc
Form 483 issued December 10, 2025
- Inspection
- Dec 2 – Dec 10, 2025
- Investigator
- Bryce A. May
- Observations
- 9
- Pages
- 10
- FEI number
- 3013870241
In short: On December 10, 2025, FDA issued a Form 483 with 9 observations to Sauna Works, Inc (FEI 3013870241) after an inspection that ran Dec 2 – Dec 10, 2025. The investigator was Bryce A. May.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design control…
- 02
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit…
- 03
Procedures for corrective and preventive action…
- 04
Written MDR procedures have…
This inspection in context
Questions about this 483
What did FDA find at Sauna Works, Inc?
FDA listed 9 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected Sauna Works, Inc?
Bryce A. May is named on this Form 483, for the inspection of Dec 2 – Dec 10, 2025. Each investigator has a profile showing what they cite most.
When was Sauna Works, Inc inspected by FDA?
The inspection ran Dec 2 – Dec 10, 2025, and the Form 483 is dated December 10, 2025.
How do I get the full Form 483 for Sauna Works, Inc?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.