Lifewatch Services Inc – FDA Inspection, Feb 11, 2010

Record Details

This FDA Inspection record concerns Lifewatch Services Inc, with an inspection on February 11, 2010, issued by the Center for Devices and Radiological Health, covering devices.

Company: Lifewatch Services Inc
Inspection Date: February 11, 2010
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · d4a4e1e7-cb70-4b49-b4e2-f4fcb2424b5e

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 647570
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 803.50(a)(2)Individual Report of Malfunction
21 CFR 820.198(a)Complete files maintained
21 CFR 820.100(b)Documentation
21 CFR 820.100(a)(4)CAPA verification/validation of corrective/preventive action
21 CFR 820.198(d)(3)Determination of relationship of device to event
21 CFR 820.20(b)(3)Management representative
21 CFR 803.17(a)(1)Lack of System for Event Evaluations
21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports

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Other FDA inspections of Lifewatch Services Inc

Date	Classification	Office	Project area
September 17, 2021	VAI	Center for Devices and Radiological Health	Compliance: Devices
April 16, 2019	VAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
May 15, 2018	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
June 1, 2016	NAI	Center for Devices and Radiological Health	Compliance: Devices
June 18, 2014	OAI	Center for Devices and Radiological Health	Compliance: Devices