Fisher Wallace Laboratories Inc. – FDA Inspection, Jun 10, 2010

Record Details

This FDA Inspection record concerns Fisher Wallace Laboratories Inc., with an inspection on June 10, 2010, issued by the Center for Devices and Radiological Health, covering devices.

Company: Fisher Wallace Laboratories Inc.
Inspection Date: June 10, 2010
Product Type: Devices
Office: Center for Devices and Radiological Health

View Company Profile

ID · c3b5e38a-5fb7-43e3-b90d-a701a6ecefd3

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 664620
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices

FDA Citations

21 CFR 820.184DHR - not or inadequately maintained
21 CFR 820.30(a)Design control - no procedures
21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
21 CFR 820.200(d)No Service reports
21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
21 CFR 803.17Lack of Written MDR Procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Fisher Wallace Laboratories Inc.

Date	Classification	Office	Project area
May 13, 2025	VAI	New York District Office	Compliance: Medical Devices
March 15, 2023	VAI	Center for Devices and Radiological Health	Compliance: Devices
June 25, 2019	NAI	Center for Devices and Radiological Health	Compliance: Devices
March 1, 2016	VAI	Center for Devices and Radiological Health	Compliance: Devices
January 6, 2015	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices