Company
United StatesF Care Systems USA, LLC, Miami, FL – FDA Inspections
Inspection records and compliance data for F Care Systems USA, LLC in Miami, Florida. 5 FDA inspections on record (1 OAI), 1 Form 483, 1 warning letter, last inspected November 27, 2023.
Company Profile
This profile covers F Care Systems USA, LLC based in Miami, Florida, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 1
- VAI
- 2
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 1
First inspected March 30, 2012. Last inspected November 27, 2023.
Most cited issue areas
- Lack of Written MDR Procedures3 inspections
- Lack of or inadequate complaint procedures2 inspections
- Lack of or inadequate procedures2 inspections
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 27, 2023 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1223804 |
| March 21, 2022 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1166746 |
| March 6, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1006384 |
| December 5, 2012 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 816257 |
| March 30, 2012 | OAI | Medical Devices & Rad Health · Compliance: Devices | 774386 |
FDA documents
Warning Letters (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
F Care Systems USA, LLC
FEI Number
3009438986
Address
755 Ne 164th Ter, Miami, Florida 33162, United States
Country
United States
ID: d9064894-2eae-4895-9fdd-1fb865df0cd8