Haven Innovation, Inc. – FDA Inspection, Mar 27, 2014

Record Details

This FDA Inspection record concerns Haven Innovation, Inc., with an inspection on March 27, 2014, issued by the Center for Devices and Radiological Health, covering devices.

Company: Haven Innovation, Inc.
Inspection Date: March 27, 2014
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 2964254f-90e9-48e8-b054-9fe8f1c299bd

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number: 871793
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.181DMR - not or inadequately maintained
21 CFR 820.75(a)Lack of or inadequate process validation
21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.20(c)Management review - Lack of or inadequate procedures
21 CFR 820.22Quality audits - Lack of or inadequate procedures
21 CFR 820.198(a)Lack of or inadequate complaint procedures
21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures

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Other FDA inspections of Haven Innovation, Inc.

Date	Classification	Office	Project area
December 17, 2015	VAI	Center for Devices and Radiological Health	Compliance: Devices
November 12, 2014	OAI	Center for Devices and Radiological Health	Compliance: Devices
May 2, 2012	VAI	Center for Devices and Radiological Health	Compliance: Devices