Company
United StatesMyocardial Solutions, Morrisville, NC – FDA Inspections
Inspection records and compliance data for Myocardial Solutions in Morrisville, North Carolina. 2 FDA inspections on record, 1 Form 483, last inspected April 23, 2025.
Company Profile
This profile covers Myocardial Solutions based in Morrisville, North Carolina, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected May 25, 2018. Last inspected April 23, 2025.
Most cited issue areas
- Nonconforming product, Lack of or inadequate procedures1 inspection
- Procedures not adequately established or maintained1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 23, 2025 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1269125 |
| May 25, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1055256 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Myocardial Solutions
FEI Number
3006015847
Address
808 Aviation Pkwy Ste 700, Morrisville, North Carolina 27560, United States
Country
United States
ID: 92d89fe3-16a5-4703-a3ca-f27753d96a45