J&T Health and Wellness LLC – FDA Inspection, Jul 30, 2021

Record Details

This FDA Inspection record concerns J&T Health and Wellness LLC, with an inspection on July 30, 2021, issued by the Center for Devices and Radiological Health, covering devices.

Company: J&T Health and Wellness LLC
Inspection Date: July 30, 2021
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · f6609d70-bbb5-4b44-9ce6-532874c005ea

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 1147619
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.80(e)Documentation
21 CFR 820.40Procedures not adequately established or maintained
21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.25(b)Training - Lack of or inadequate 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 820.50Purchasing controls, Lack of or inadequate procedures
21 CFR 820.22Quality Audits - defined intervals
21 CFR 803.17(a)(2)Lack of System for Determining MDR Events

Showing 10 of 11 citations.

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Other FDA inspections of J&T Health and Wellness LLC

Date	Classification	Office	Project area
October 18, 2023	VAI	Center for Devices and Radiological Health	Radiation Control and Health Safety Act
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
February 28, 2012	VAI	Center for Devices and Radiological Health	Compliance: Devices