Company
United StatesMonarch Medical Technologies, LLC, Charlotte, NC – FDA Inspections
Inspection records and compliance data for Monarch Medical Technologies, LLC in Charlotte, North Carolina. 3 FDA inspections on record, 1 Form 483, last inspected May 10, 2024.
Company Profile
This profile covers Monarch Medical Technologies, LLC based in Charlotte, North Carolina, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected December 10, 2015. Last inspected May 10, 2024.
Most cited issue areas
- Design input - documentation1 inspection
- Design validation - documentation1 inspection
- Investigation of device failures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 10, 2024 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1241052 |
| February 19, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1079816 |
| December 10, 2015 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 953450 |
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
Monarch Medical Technologies, LLC
FEI Number
3009864844
Address
112 S Tryon St Ste 800, Charlotte, North Carolina 28284, United States
Country
United States
ID: 86f54049-a3cd-4929-acd9-c2deb50ba951