Inspections, Compliance, Enforcement, and Criminal Investigations
Safer Sleep, LLC Response Letter
3322 West End Ave., Suite 705
Nashville, Tennessee 37203
April 14th, 2009
WARNING LETTER NO. 2008-NOL-10
Tylor Thornburg District Director
U.S. Food and Drug Administration
New Orleans District
404 BNA Drive
Building 200 – Suite 500
Nashville, TN 37217
Dear Mr. Thornburg:
Safer Sleep manufactures and distributes the SAFERsleep System, this is software based product intended for use by an anesthetist to assist in the safe administration of drugs and record keeping of this and other data during an anesthetic procedure. Section 510k pre market notification listing for the device was confirmed on October 27th, 2005, numbered K050883.
In November 2007 the Food and Drug Administration team inspected the Safer Sleep US facilities. The inspection occurred on November 13, 16 and 20, 2007. At the end of inspection the Company was provided with the FDA Form 483 listing the inspection team’s observations, which Safer Sleep responded to in December 4th 2007. Then in late May 2008, the Company received a Warning Letter dated 27th May 2008.
As a result of receiving the FDA observations the Company initiated a program for implementing quality systems across all development, product testing and business activities. Safer Sleep contracted the services of a professional quality assurance and regulatory affairs company (b)(4) to assist with the Company understanding and application of the quality system and processes. The Company management undertook a two day training program on quality systems on May 27th and 28th, 2008 and prepared an action plan for the implementation of quality systems and processes. It was on the last day of this management training the Company received the Warning letter.
Safer Sleep lacked LLC Level 1 and 2 documents across most of the organization and there were gaps in some of the quality process areas for Level 3 & 4 documentation. To address this we systematically developed Level 1 and documentation standards and change control systems. The Company then focused on other areas identified in the Warning Letter and reviewed all core processes to ensure they were documented and implemented at all levels in the organization. Individual groups of employees have continued to develop Level 3 & 4 and some Level 2 documentation as they relate to their area of work. This has resulted in the definition, documentation and implementation of quality systems and processes across the organization.
In November 2008, the Company closed its US operations for commercial reasons.
An update on the status of Safer Sleep’s implementation of quality systems was sent to the FDA office in a letter dated November 10, 2008. The letter was sent to the FDA Compliance Officer along with accompanying support documentation. In this package the Company described each Warning Letter issue, the current status of the quality systems relating to this issue along with a list of the supporting documentation and actions to complete the implementation. The supporting documentation was available for review on an enclosed CD.
The response from the FDA was received in a letter dated January 16, 2009, stating “It appears your firm is working towards addressing its deficiencies in response to our November 20, 2007, FDA 483; however whether any corrective actions have been implemented would have to be evaluated during a reinspection of your firm. We are aware though the facilities, located at 3322 West End Ave, Suite 705, Nashville, Tennessee is closing and all operations are moving to the New Zealand location. Therefore a reinspection of the firm is not possible.”
In January 2009, the (b)(4) carried out an internal audit of Safer Sleep’s quality system’s at the New Zealand site and found significant progress had been made. The Company continues to improve and embed quality systems into its operations in New Zealand and other markets.
Due to the fact that the operations in the United States were closed and therefore there is no possibility for a re-inspection to occur to assure the deficiencies were addressed, Safer Sleep has constructed this response to the Warning Letter 2008-NOL-10, sent May 27, 2008, and requested this letter be posted on the FDA website beside the original Safer Sleep Warning Letter.
The Company is committed to continue to implement, improve and embed quality systems as a fundamental approach to “the way we work”.
Should further information be required from the Company please contact either the Safer Sleep regulatory agent in the US, Steve Chernoff or the Safer Sleep CEO, Sue Wright. The contact details are listed below:
Steve Chernoff, Vice President, Drug and Device Development Co., 15600 Redmond Way #205, Redmond, WA 98052, USA; PO Box 3515, Redmond, WA 98073-3515, US.
Phone: +1 425 861 8262
Fax: +1 425 869 5854
Sue Wright, CEO, Safer Sleep, PPO Box 11 490, Ellerslie, Auckland, 1542, New Zealand
Phone: +64 9 526 1543 Ext 18.
Mobile: [ (7)(C) ]
Fax: +64 9 526 1541
Sue Wright, CEO