Health Science Products Inc – FDA Inspection, Aug 10, 2011

Record Details

This FDA Inspection record concerns Health Science Products Inc, with an inspection on August 10, 2011, issued by the Center for Devices and Radiological Health, covering devices.

Company: Health Science Products Inc
Inspection Date: August 10, 2011
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · f1acd015-4ec4-4ad7-b7cc-4222748d8ccc

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number: 735883
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices

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 820.40Lack of procedures, or not 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 820.70(a)Process control procedures, Lack of or inadequate procedures
21 CFR 820.20(e)Quality System 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
October 30, 2017	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