Company
United StatesPathy Medical, LLC, Eden Prairie, MN – FDA Inspections
Inspection records and compliance data for Pathy Medical, LLC in Eden Prairie, Minnesota. 2 FDA inspections on record, 1 Form 483, last inspected November 19, 2024.
Company Profile
This profile covers Pathy Medical, LLC based in Eden Prairie, Minnesota, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 0
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected June 27, 2019. Last inspected November 19, 2024.
Most cited issue areas
- Lack/Inad procedure-Monitoring/Control of Validated Proces1 inspection
- Lack of or inadequate procedures1 inspection
- Management review - defined interval, sufficient frequency1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 19, 2024 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Medical Devices | 1254558 |
| June 27, 2019 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1095561 |
FDA documents
Form 483s (1)
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Company Information
Name
Pathy Medical, LLC
FEI Number
3015042181
Address
7625 Golden Triangle Dr Ste G, Eden Prairie, Minnesota 55344, United States
Country
United States
ID: b4bc8fcb-5631-4477-90fd-7b69223b1e5c