Expanse Medical Inc.
Form 483 issued January 15, 2026 · Pleasanton, California
- Inspection
- Jan 9 – Jan 15, 2026
- Investigator
- Sara M. Onyango
- Observations
- 3
- Pages
- 4
- FEI number
- 3017823876
In short: On January 15, 2026, FDA issued a Form 483 with 3 observations to Expanse Medical Inc. in Pleasanton, California (FEI 3017823876) after an inspection that ran Jan 9 – Jan 15, 2026. The investigator was Sara M. Onyango. Most observations concern design controls and cAPA.
At a glance
Design controls and capa account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design validation have…
- 02
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 03
The information required by the Global Unique Device Identification Database for each medical device version or…
This inspection in context
Sara M. Onyango
9 documents · 2019–2026
Cites 820.30(f) (design controls) more than any other section. Most of their documents are for sites in Massachusetts.
The firmExpanse Medical Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(g)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Expanse Medical Inc.?
FDA listed 3 observations on this Form 483, mostly about design controls and cAPA. The opening words of each observation are shown on this page.
Who inspected Expanse Medical Inc.?
Sara M. Onyango is named on this Form 483, for the inspection of Jan 9 – Jan 15, 2026. Each investigator has a profile showing what they cite most.
When was Expanse Medical Inc. inspected by FDA?
The inspection ran Jan 9 – Jan 15, 2026, and the Form 483 is dated January 15, 2026.
How do I get the full Form 483 for Expanse Medical 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.