FDA Compliance Help Desk, Inc.

AUDITING

The Quality Systems Investigation Technique (QSIT) is an inspectional process used by the FDA to assess a medical device manufacturer’s compliance with the Quality System Regulation and related regulations. 

We conduct QSIT audits:

•          At key suppliers

•           To prepare for an FDA inspection

•           To improve one or more of the modules shown

•           After receiving a FDA 483

•           Due diligence prior to acquisition

Call 919.942.1634 For more information

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FDA Compliance Help Desk™

1289 N. Fordham Blvd. Suite A-128

Chapel Hill, NC 27517 USA

Phone 919.942.1634 

info@FDAcomplianceHelp.com

Copyright © 2004 - 2005 FDA Compliance Help Desk, Inc.
Last modified: April 16, 2007

FDA Compliance Help Desk, Inc. is a for profit NC corporation and is not affiliated with the U.S. Department of Health and Human Services.