Company
United StatesTerumo Medical Corporation, Elkton, MD – FDA Inspections
Inspection records and compliance data for Terumo Medical Corporation in Elkton, Maryland. 9 FDA inspections on record (1 OAI), 3 Form 483s, last inspected September 11, 2026.
Company Profile
This profile covers Terumo Medical Corporation based in Elkton, Maryland, United States.
FDA Inspection History
- FDA inspections
- 9
- OAI
- 1
- VAI
- 2
- NAI
- 4
- Unclassified
- 2
- Form 483s
- 3
- Warning letters
- 0
First inspected September 2, 2009. Last inspected September 11, 2026.
Most cited issue areas
- Nonconforming product control2 inspections
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Corrective action not taken1 inspection
FDA inspections (9)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 11, 2026 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1332082 |
| May 1, 2026 | Not classified | Medical Devices & Rad Health | 1317212 |
| October 28, 2022 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1182280 |
| June 20, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1094113 |
| January 13, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1003680 |
| October 23, 2015 | OAI | Medical Devices & Rad Health · Compliance: Devices | 950051 |
| September 12, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 847650 |
| June 5, 2013 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 834788 |
| September 2, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 610029 |
FDA documents
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Company Information
Name
Terumo Medical Corporation
FEI Number
1118880
Address
950 Elkton Blvd, Elkton, Maryland 21921, United States
Country
United States
ID: 436e47e6-b836-4f48-9dbf-0a2f76c31902