FEI 1317547
Harmac Medical Products, Inc.
2201 BAILEY AVE., BUFFALO, NY, US
MDR events1All time
Recalls0All time
Registered products15
Establishment typeManufactureManufacture Medical Device for Another Party (Contract Manufacturer)
Registered product codes
15 product codes
Recent MDR events
1 on file
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 1317547.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Oct 4, 2024
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Oct 4, 2024
Postmarket Assurance: Devices · Citations posted
Inspection citations
1 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.80(d)Oct 4, 2024
Lack of or inadequate final acceptance procedures
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.