FDA Inspection
J&T Health and Wellness LLCJ&T Health and Wellness LLC – FDA Inspection, Sep 21, 2012
Record Details
This FDA Inspection record concerns J&T Health and Wellness LLC, with an inspection on September 21, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- J&T Health and Wellness LLC
- Inspection Date
- September 21, 2012
- Product Type
- Devices
View Company Profile
ID · 4da0b012-685e-4830-9a54-69b204182afb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 800282
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 806.20(a)Records not kept
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Other FDA inspections of J&T Health and Wellness LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| October 18, 2023 | VAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| July 30, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 24, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 4, 2017 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 28, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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