Howard Instruments Inc – FDA Inspection, Dec 18, 2008

Record Details

This FDA Inspection record concerns Howard Instruments Inc, with an inspection on December 18, 2008, issued by the Center for Devices and Radiological Health, covering devices.

Company: Howard Instruments Inc
Inspection Date: December 18, 2008
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 3b5b5948-91ba-4053-80c9-bd981d1f1a0a

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 552193
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.198(c)Investigation of device failures
21 CFR 820.25(b)Training
21 CFR 820.20(c)Management review - Lack of or inadequate procedures
21 CFR 820.184Lack of or inadequate DHR procedures
21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
21 CFR 820.22Quality Audits - defined intervals
21 CFR 820.198(e)(3)Device identification and control number
21 CFR 820.181(a)DMR device specifications
21 CFR 820.100(a)Lack of or inadequate procedures

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Other FDA inspections of Howard Instruments Inc

Date	Classification	Office	Project area
November 8, 2016	VAI	Center for Devices and Radiological Health	Compliance: Devices
October 4, 2012	OAI	Center for Devices and Radiological Health	Compliance: Devices
September 14, 2010	OAI	Center for Devices and Radiological Health	Compliance: Devices