Biomedix Wai – FDA Inspection, Mar 4, 2013

Record Details

This FDA Inspection record concerns Biomedix Wai, with an inspection on March 4, 2013, issued by the Center for Devices and Radiological Health, covering devices.

Company: Biomedix Wai
Inspection Date: March 4, 2013
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 1d52da7c-7157-436f-8fd4-cdf870e2b029

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 821884
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.75(a)Lack of or inadequate process validation
21 CFR 820.40Lack of procedures, or not maintained
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.30(a)Design control - no procedures
21 CFR 820.20(c)Management review - Lack of or inadequate procedures
21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
21 CFR 820.22Quality Audits - defined intervals

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Other FDA inspections of Biomedix Wai

Date	Classification	Office	Project area
November 18, 2024	NAI	Center for Devices and Radiological Health	Compliance: Devices
June 3, 2022	VAI	Center for Devices and Radiological Health	Compliance: Devices
October 31, 2019	OAI	Center for Devices and Radiological Health	Compliance: Devices
June 8, 2018	VAI	Center for Devices and Radiological Health	Compliance: Devices
December 9, 2015	VAI	Center for Devices and Radiological Health	Compliance: Devices