INSPIRE MEDICAL SYSTEMS INC

FDA inspection history on file, 2025

1
Form 483

Every document, by year

  • Form 483

2025: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2025One Form 483.

Cited most

Across all INSPIRE MEDICAL SYSTEMS observations on file

  • 21 CFR 803.17
    What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?
    1
  • 21 CFR 820.198
    Complaint files
    1

The complete INSPIRE MEDICAL SYSTEMS file.

All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.

$99

The documents one by one, while the file is prepared

See the documents

Documents

1 on file, newest first
DateDocumentPrice
2025-12-19483 Form 483$99

Investigators on these documents

Alicia U. Jacobo (1)

FEI number 3030499299 · most recent document Dec 19, 2025

About INSPIRE MEDICAL SYSTEMS INC

How many FDA Form 483s has INSPIRE MEDICAL SYSTEMS INC received?

FDA Intel has 1 Form 483 on file for INSPIRE MEDICAL SYSTEMS INC; the most recent is dated Dec 19, 2025.

When was INSPIRE MEDICAL SYSTEMS INC last inspected by FDA?

The most recent FDA inspection document on file for INSPIRE MEDICAL SYSTEMS INC is a Form 483 dated Dec 19, 2025.

What did FDA cite at INSPIRE MEDICAL SYSTEMS INC?

The regulations cited most in the observations on file for INSPIRE MEDICAL SYSTEMS INC are 21 CFR 803.17 (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 1 time; 21 CFR 820.198 (Complaint files), 1 time.