Company
United StatesMed-Dyne, Inc., Louisville, KY – FDA Inspections
Inspection records and compliance data for Med-Dyne, Inc. in Louisville, Kentucky. 5 FDA inspections on record, 2 Form 483s, last inspected November 06, 2025.
Company Profile
This profile covers Med-Dyne, Inc. based in Louisville, Kentucky, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected June 15, 2011. Last inspected November 6, 2025.
Most cited issue areas
- Lack of or inadequate procedures2 inspections
- Design validation - documentation1 inspection
- Documentation1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 6, 2025 | Not classified | Medical Devices & Rad Health | 1289796 |
| January 30, 2023 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1195952 |
| May 21, 2019 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1091481 |
| November 1, 2016 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 999363 |
| June 15, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 728705 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Med-Dyne, Inc.
FEI Number
3002947950
Address
2775 S Floyd St, Louisville, Kentucky 40209, United States
Country
United States
ID: 4137b0f6-2fbd-47e2-91b7-ad00ca650019