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Expanse Medical Inc.

FDA establishment 3017823876, Pleasanton, California, United States. Part of Expanse Medical's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.

  • Inspections: 1
  • Official action indicated: 0
  • Last inspection ended: Jan 15, 2026
  • Warning letters: 0

Inspections by Fiscal Year

FY2018 to FY2027 to date; 0 classified OAI

Most Cited at This Site

Inspections citing each reference

Inspections

1 inspections, newest first
EndedProduct and areaCitationsClassification
Jan 15, 2026Devices · Postmarket Assurance: DevicesDevices · Compliance: Devices
3 cited references
  • 21 CFR 830.300(a). Devices subject to device identification GUDID data submission requirements. The information required by the Global Unique Device Identification Database for each medical device version or model required to bear a unique device identifier (UDI) was not provided.
  • 21 CFR 820.198(a). Lack of or inadequate complaint procedures Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
  • 21 CFR 820.30(g). Design validation- Lack of or inadequate procedures Procedures for design validation have not been adequately established.
No Action Indicated (NAI)

Identifiers

FEI number
3017823876
FDA firm profile
Data Dashboard

An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm. FDA Data Dashboard and warning letters

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.