INSPIRE MEDICAL SYSTEMS INC
Form 483 issued December 19, 2025
- Inspection
- Dec 15 – Dec 19, 2025
- Investigator
- Alicia U. Jacobo
- Observations
- 1
- Pages
- 7
- FEI number
- 3030499299
In short: On December 19, 2025, FDA issued a Form 483 with 1 observation to INSPIRE MEDICAL SYSTEMS INC (FEI 3030499299) after an inspection that ran Dec 15 – Dec 19, 2025. The investigator was Alicia U. Jacobo. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 820.198 (1×) · 803.17 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
This inspection in context
Alicia U. Jacobo
4 documents · 2024–2026
Cites 803.17 (what are the requirements for developing, maintaining, and implementing written mdr procedures that apply to me?) more than any other section. Most of their documents are for sites in Minnesota.
The firmINSPIRE MEDICAL SYSTEMS INC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.198
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at INSPIRE MEDICAL SYSTEMS INC?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected INSPIRE MEDICAL SYSTEMS INC?
Alicia U. Jacobo is named on this Form 483, for the inspection of Dec 15 – Dec 19, 2025. Each investigator has a profile showing what they cite most.
When was INSPIRE MEDICAL SYSTEMS INC inspected by FDA?
The inspection ran Dec 15 – Dec 19, 2025, and the Form 483 is dated December 19, 2025.
How do I get the full Form 483 for INSPIRE MEDICAL SYSTEMS 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.