J&t Health And Wellness Llc
2442 23rd St N, Saint Petersburg, FL, US
Registered product codes
2 product codes
Recent MDR events
1 on file
Compliance history
Matched by FEI 1000525872.
FDA inspections
3 on file
- Voluntary Action Indicated (VAI)Oct 18, 2023
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Oct 18, 2023
Postmarket Assurance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Oct 18, 2023
Radiation Control and Health Safety Act · Citations posted
Inspection citations
8 on file
Top cited requirements
Compare to industry ↗21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
121 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
121 CFR 820.70(i)Documentation of software validation
121 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
121 CFR 820.80(e)Documentation
121 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
1
- 21 CFR 820.30(g)Oct 18, 2023
Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(i)Oct 18, 2023
Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.70(i)Oct 18, 2023
Documentation of software validation
- 21 CFR 820.72(a)Oct 18, 2023
Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.80(e)Oct 18, 2023
Documentation
- 21 CFR 820.90(a)Oct 18, 2023
Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.100(a)Oct 18, 2023
Lack of or inadequate procedures
- 21 CFR 820.198(a)Oct 18, 2023
Lack of or inadequate complaint procedures
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.