Compass Richmar LLC – FDA Inspection, Apr 9, 2009

Record Details

This FDA Inspection record concerns Compass Richmar LLC, with an inspection on April 9, 2009, issued by the Center for Devices and Radiological Health, covering devices.

Company: Compass Richmar LLC
Inspection Date: April 9, 2009
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 132bee47-b403-4af2-a3a3-b4882ff9463f

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 575250
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.100(a)(1)Analysis of data sources
21 CFR 820.100(a)(2)Investigation
21 CFR 820.40(a)Document locations, Dissemination, etc.
21 CFR 820.25(b)Training records
21 CFR 820.80(b)Incoming inspection, testing, verification
21 CFR 820.20Management responsibility
21 CFR 820.20(b)(3)Management representative
21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
21 CFR 820.140Lack of or inadequate procedures for handling
21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures

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Other FDA inspections of Compass Richmar LLC

Date	Classification	Office	Project area
July 14, 2016	NAI	Center for Devices and Radiological Health	Compliance: Devices
July 30, 2014	VAI	Center for Devices and Radiological Health	Compliance: Devices
June 28, 2012	OAI	Center for Devices and Radiological Health	Compliance: Devices
August 24, 2011	OAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices