Arnold Tuber Industries, LLC – FDA Inspection, Jul 9, 2010

Record Details

This FDA Inspection record concerns Arnold Tuber Industries, LLC, with an inspection on July 9, 2010, issued by the Center for Devices and Radiological Health, covering devices.

Company: Arnold Tuber Industries, LLC
Inspection Date: July 9, 2010
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · bf644402-5868-47b9-9057-1c7b9a1a5140

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 671799
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.181DMR - not or inadequately maintained
21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
21 CFR 820.30(a)Design control - no procedures
21 CFR 820.70(a)Production processes
21 CFR 820.22Quality Audit/Reaudit - conducted
21 CFR 820.70(i)Documentation of software validation
21 CFR 803.17Lack of Written MDR Procedures

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Other FDA inspections of Arnold Tuber Industries, LLC

Date	Classification	Office	Project area
February 20, 2025	NAI	New York District Office	Postmarket Assurance: Medical Devices
March 14, 2022	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
November 7, 2019	VAI	Center for Devices and Radiological Health	Compliance: Devices
June 23, 2017	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
December 4, 2012	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices