Medivators Inc – FDA Inspection, Mar 13, 2009

Record Details

This FDA Inspection record concerns Medivators Inc, with an inspection on March 13, 2009, issued by the Center for Devices and Radiological Health, covering devices.

Company: Medivators Inc
Inspection Date: March 13, 2009
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 3a573720-34dc-4c4e-95f7-ef57e911c15d

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 566785
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.30(b)Establish the design and development plan
21 CFR 820.198(a)General
21 CFR 820.100(b)Documentation
21 CFR 820.100(a)(1)Statistical methodology
21 CFR 820.30(c)Incomplete, ambiguous, conflicting design requirements
21 CFR 820.25(b)Training records
21 CFR 820.22Quality audits - Lack of or inadequate procedures
21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
21 CFR 820.50(b)Approval, inadequate purchasing data

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Other FDA inspections of Medivators Inc

Date	Classification	Office	Project area
March 31, 2017	NAI	Center for Devices and Radiological Health	Compliance: Devices
December 17, 2012	VAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
April 13, 2010	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices