Neurotherm LLC – FDA Inspection, Jan 9, 2013

Record Details

This FDA Inspection record concerns Neurotherm LLC, with an inspection on January 9, 2013, issued by the Center for Devices and Radiological Health, covering devices.

Company: Neurotherm LLC
Inspection Date: January 9, 2013
Product Type: Devices
Office: Center for Devices and Radiological Health

View Company Profile

ID · 21011464-30aa-494f-b524-bdf90ac9b66c

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 812556
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 803.50(a)(1)Report of Death or Serious Injury
21 CFR 820.30(g)Design validation - user needs and intended uses
21 CFR 820.40(a)Not approved or obsolete document retrieval
21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
21 CFR 820.198(a)Lack of or inadequate complaint procedures
21 CFR 820.25(b)Training - Lack of or inadequate procedures
21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures

Showing 10 of 13 citations.

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Neurotherm LLC

Date	Classification	Office	Project area
February 4, 2016	VAI	Center for Devices and Radiological Health	Compliance: Devices
April 26, 2012	OAI	Center for Devices and Radiological Health	Compliance: Devices
December 4, 2008	VAI	Center for Devices and Radiological Health	Compliance: Devices