Richard Wolf Medical Instruments Corp. – FDA Inspection, Oct 10, 2014

Record Details

This FDA Inspection record concerns Richard Wolf Medical Instruments Corp., with an inspection on October 10, 2014, issued by the Center for Devices and Radiological Health, covering devices.

Company: Richard Wolf Medical Instruments Corp.
Inspection Date: October 10, 2014
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · dd18b8bc-8323-4af2-9632-e986445506af

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 900890
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices

FDA Citations

21 CFR 803.50(b)(3)Conducting an Investigation
21 CFR 820.100(b)Documentation
21 CFR 820.198(d)Records of MDR Investigation
21 CFR 820.25(b)Training - Lack of or inadequate procedures
21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
21 CFR 820.22Quality Audit/Reaudit - conducted
21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
21 CFR 820.20(b)Lack of or inadequate organizational structure

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Other FDA inspections of Richard Wolf Medical Instruments Corp.

Date	Classification	Office	Project area
January 13, 2025	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
April 19, 2023	NAI	Center for Devices and Radiological Health	Compliance: Devices
March 18, 2020	VAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
July 17, 2018	VAI	Center for Devices and Radiological Health	Compliance: Devices
May 8, 2013	OAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices