Company
United StatesClarity Diagnostics, LLC, Boca Raton, FL – FDA Inspections
Inspection records and compliance data for Clarity Diagnostics, LLC in Boca Raton, Florida. 3 FDA inspections on record, 1 Form 483, last inspected April 06, 2022.
Company Profile
This profile covers Clarity Diagnostics, LLC based in Boca Raton, Florida, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected May 23, 2013. Last inspected April 6, 2022.
Most cited issue areas
- Lack of or inadequate complaint procedures2 inspections
- Lack of Written MDR Procedures2 inspections
- Environmental control Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 6, 2022 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1169763 |
| May 8, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1088913 |
| May 23, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 833184 |
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
Clarity Diagnostics, LLC
FEI Number
3004043187
Address
1060 Holland Dr Ste B, Boca Raton, Florida 33487, United States
Country
United States
ID: d00e9188-408f-49ef-8fb8-1790097a42be