Expanse Medical Inc.

FDA inspection history in Pleasanton, California, 2026

1
Form 483

Every document, by year

  • Form 483

2026: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2026One Form 483, at Pleasanton, California.

Cited most

Across all Expanse Medical observations on file

The complete Expanse Medical 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

Sites

Documents

1 on file, newest first
DateDocumentPrice
2026-01-15483 Form 483$99

Investigators on these documents

Sara M. Onyango (1)

FEI number 3017823876 · most recent document Jan 15, 2026

About Expanse Medical Inc.

How many FDA Form 483s has Expanse Medical Inc. received?

FDA Intel has 1 Form 483 on file for Expanse Medical Inc.; the most recent is dated Jan 15, 2026.

When was Expanse Medical Inc. last inspected by FDA?

The most recent FDA inspection document on file for Expanse Medical Inc. is a Form 483 dated Jan 15, 2026, for the site in Pleasanton, California.

What did FDA cite at Expanse Medical Inc.?

The regulations cited most in the observations on file for Expanse Medical Inc. are 21 CFR 820.198(a) (Complaint files), 1 time; 21 CFR 820.30(g) (Design controls), 1 time; 21 CFR 830.300(a) (Devices subject to device identification data submission requirements), 1 time.