Company
United StatesBreathe E-Z Systems, Inc., Leawood, KS – FDA Inspections
Inspection records and compliance data for Breathe E-Z Systems, Inc. in Leawood, Kansas. 4 FDA inspections on record, 1 Form 483, last inspected May 22, 2023.
Company Profile
This profile covers Breathe E-Z Systems, Inc. based in Leawood, Kansas, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected June 18, 2009. Last inspected May 22, 2023.
Most cited issue areas
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate DHR procedures1 inspection
- Lack of or inadequate procedures - Acceptance activities1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 22, 2023 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1206550 |
| July 17, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1096539 |
| November 7, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 807476 |
| June 18, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 590070 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Breathe E-Z Systems, Inc.
FEI Number
3004141536
Address
12702 Cherokee Ln, Leawood, Kansas 66209, United States
Country
United States
ID: 1e53cae8-29f4-4357-a67e-7c4c6e508252