Company
United StatesEmpyrean Medical Systems Inc, Boca Raton, FL – FDA Inspections
Inspection records and compliance data for Empyrean Medical Systems Inc in Boca Raton, Florida. 1 FDA inspection on record, last inspected June 05, 2024.
Company Profile
This profile covers Empyrean Medical Systems Inc based in Boca Raton, Florida, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
Inspected June 5, 2024.
Most cited issue areas
- Communication with dealers et. al.1 inspection
- Complaints1 inspection
- Design changes - Lack of or Inadequate Procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 5, 2024 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1240157 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Empyrean Medical Systems Inc
FEI Number
3023344262
Address
3010 N Military Trl Ste 220, Boca Raton, Florida 33431, United States
Country
United States
ID: e5fa1a61-737b-48ab-a3af-bd8e98a6a994