Hill-Rom Inc – FDA Inspection, Feb 13, 2014

Record Details

This FDA Inspection record concerns Hill-Rom Inc, with an inspection on February 13, 2014, issued by the Center for Devices and Radiological Health, covering devices.

Company: Hill-Rom Inc
Inspection Date: February 13, 2014
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · aed4ffda-049d-44a0-9df1-108904ee2b6b

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 865826
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.198(c)Investigation of device failures
21 CFR 820.30(f)Design verification - output does not meet input requirement
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.198(a)Lack of or inadequate complaint procedures
21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
21 CFR 803.17Lack of Written MDR Procedures

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Other FDA inspections of Hill-Rom Inc

Date	Classification	Office	Project area
April 12, 2024	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
November 19, 2021	VAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
November 10, 2017	Not classified	Detroit District Office
December 19, 2014	VAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
January 11, 2013	OAI	Center for Devices and Radiological Health	Compliance: Devices