Company
United StatesPremier Heart, LLC, Port Washington, NY – FDA Inspections
Inspection records and compliance data for Premier Heart, LLC in Port Washington, New York. 6 FDA inspections on record, 1 Form 483, last inspected November 15, 2024.
Company Profile
This profile covers Premier Heart, LLC based in Port Washington, New York, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 3
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected June 10, 2011. Last inspected November 15, 2024.
Most cited issue areas
- Complaints2 inspections
- Lack of or inadequate procedures2 inspections
- Acceptable supplier records, inadequate records1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 15, 2024 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1256892 |
| September 28, 2021 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1153701 |
| February 8, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1040432 |
| June 11, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 931172 |
| March 15, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 822887 |
| June 10, 2011 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 730081 |
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
Premier Heart, LLC
FEI Number
3003289183
Address
110 Main St Ste 201, Port Washington, New York 11050, United States
Country
United States
ID: 9bde989f-8561-4595-8aed-fe2272284c6a