Company
United StatesPulmodyne Inc., Indianapolis, IN – FDA Inspections
Inspection records and compliance data for Pulmodyne Inc. in Indianapolis, Indiana. 5 FDA inspections on record (1 OAI), 1 Form 483, last inspected April 22, 2025.
Company Profile
This profile covers Pulmodyne Inc. based in Indianapolis, Indiana, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 1
- VAI
- 3
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected February 10, 2010. Last inspected April 22, 2025.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design control - no procedures1 inspection
- Environmental control Lack of or inadequate procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 22, 2025 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1268055 |
| January 10, 2018 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1039908 |
| September 2, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 941634 |
| March 22, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 823725 |
| February 10, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 644965 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Pulmodyne Inc.
FEI Number
1832562
Address
2055 Executive Dr, Indianapolis, Indiana 46241, United States
Country
United States
ID: 8c17b704-2050-4c41-977d-f2141366a299