Health Science Products Inc – FDA Inspection, Oct 30, 2017

Record Details

This FDA Inspection record concerns Health Science Products Inc, with an inspection on October 30, 2017, issued by the Center for Devices and Radiological Health, covering devices.

Company: Health Science Products Inc
Inspection Date: October 30, 2017
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Wendy R. Blame (Issuing Officer)

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ID · c0ad4275-64e1-48a7-b17a-c6c5765d8fb7

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1030199
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 820.80(e)Documentation
21 CFR 820.184DHR - not or inadequately maintained
21 CFR 820.181DMR - not or inadequately maintained
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.198(a)Lack of or inadequate complaint procedures
21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
21 CFR 803.17Lack of Written MDR Procedures

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Other FDA inspections of Health Science Products Inc

Date	Classification	Office	Project area
August 23, 2019	VAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
March 3, 2016	NAI	Center for Devices and Radiological Health	Compliance: Devices
January 27, 2015	VAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
January 23, 2014	OAI	Center for Devices and Radiological Health	Compliance: Devices
November 2, 2012	OAI	Center for Devices and Radiological Health	Compliance: Devices