FDA Inspection
J&T Health and Wellness LLCJ&T Health and Wellness LLC – FDA Inspection, Mar 14, 2011
Record Details
This FDA Inspection record concerns J&T Health and Wellness LLC, with an inspection on March 14, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- J&T Health and Wellness LLC
- Inspection Date
- March 14, 2011
- Product Type
- Devices
View Company Profile
ID · 7c453307-d9d8-4c86-95bf-5899700b3f5a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 713583
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 820.80(b)Incoming acceptance records, documentation
- 21 CFR 820.40(b)Document changes, review and approval, communication
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.120(b)Examination for accuracy
- 21 CFR 820.20(a)Management ensuring quality policy is understood
- 21 CFR 820.25(b)Training records
- 21 CFR 820.50(a)(1)Documented evaluation
- 21 CFR 1040.20(c)(2)(iv)Timer resetting and causing resumption of radiation emission
- 21 CFR 1002.13Failure to submit
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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 |
| September 21, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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