FDA Inspection
J&T Health and Wellness LLCJ&T Health and Wellness LLC – FDA Inspection, Aug 4, 2017
Record Details
This FDA Inspection record concerns J&T Health and Wellness LLC, with an inspection on August 4, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Lisa A. Stura (Issuing Officer)
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ID · 32f97aa7-df8e-4d14-8254-6a6f60ee8760
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1021977
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 803.17Lack of Written MDR Procedures
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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 |
| September 21, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 28, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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