Healthy Spirit, LLC – FDA Inspection, Jul 6, 2017

Record Details

This FDA Inspection record concerns Healthy Spirit, LLC, with an inspection on July 6, 2017, issued by the Center for Devices and Radiological Health, covering devices.

Company: Healthy Spirit, LLC
Inspection Date: July 6, 2017
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: James M. Simpson (Company Rep)

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ID · c867238d-9e89-4a92-9763-4de29991a332

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1017146
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 820.170(a)Lack of or inadequate instructions
21 CFR 820.25(a)Personnel
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.30(a)Design control - no procedures
21 CFR 820.184Lack of or inadequate DHR procedures
21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
21 CFR 820.20(c)Management review - Lack of or inadequate procedures
21 CFR 820.22Quality audits - Lack of or inadequate procedures
21 CFR 820.198(a)Lack of or inadequate complaint procedures
21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures

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Other FDA inspections of Healthy Spirit, LLC

Date	Classification	Office	Project area
November 3, 2023	VAI	Center for Devices and Radiological Health	Compliance: Devices
April 29, 2014	NAI	Center for Devices and Radiological Health	Compliance: Devices
October 29, 2013	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
August 28, 2012	VAI	Center for Devices and Radiological Health	Compliance: Devices