Company
IrelandHarmac Medical Products, Ltd., Castlerea, Ireland – FDA Inspections
Inspection records and compliance data for Harmac Medical Products, Ltd. in Castlerea. 5 FDA inspections on record, last inspected June 01, 2023.
Company Profile
This profile covers Harmac Medical Products, Ltd. based in Castlerea, Ireland.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 1
- NAI
- 4
- Form 483s
- 0
- Warning letters
- 0
First inspected March 14, 2013. Last inspected June 1, 2023.
Most cited issue areas
- Lack of or inadequate procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 1, 2023 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1208757 |
| January 31, 2020 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1123179 |
| April 1, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 967590 |
| March 6, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 872440 |
| March 14, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 828032 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Harmac Medical Products, Ltd.
FEI Number
3002468842
Address
Ida Business Park, Castlerea, Ireland
Country
Ireland
ID: f7aaface-70b5-4148-98e1-ff397a7424f6