The satellite programs were included in the QSIT Inspection due to their correlation in the inspection process with the related subsystem. What is QSIT? ◇ Moves FDA closer to Global Harmonization guideline for regulatory auditing of quality systems of medical device manufacturers. US FDA’s Quality System Inspection Technique – or QSIT – isn’t being followed to the “T” by many agency investigators, say industry experts, including two who.

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Fall within these bounds, and you can anticipate an FDA inspection at your facility. For the scope of this article, though, we will focus specifically on the inspection of medical device manufacturers. Each tda intended to help protect the public from unsafe products, but the focus and expectations of each type of inspection are different. Pre-Approval Inspections are conducted after a company qait an application to FDA to market a new product.

These inspections focus on verifying data included in the application, and confirming that the facility is capable of manufacturing said product.

FDA’s Guide to Inspections of Quality Systems (QSIT)

The outcome of a pre-approval inspection is that inspectors will recommend for or against FDA approval. A compliance follow-up is conducted to verify the adequate correction of previous violations, to document continuing violations, or to support future regulatory action. The source of the report can be the manufacturer e. These inspections typically are more in-depth than routine inspections, and they may not follow a QSIT approach.


FDA QSIT | MasterControl

Will you know when FDA is coming? Firms with a history of violative inspections will not be granted this luxury, and FDA may show up unannounced. FDA inspection of a foreign establishment typically is preannounced two to three months in advance to allow time for travel and scheduling logistics.

Ever wonder how FDA chooses which firms should be selected for a routine inspection? FDA uses a risk-based approach. The Device Listing database is used to identify which devices each firm distributes.

The firms then are prioritized by risk: Firms that have recently introduced a new device to the market also are given higher priority, as well as those that have had significant prior violations and complaints. The majority of inspections are routine inspections.

FDA QSIT – Quality System Inspection Technique

QSIT identifies the four major subsystems of the quality system: It evaluates and describes the purpose and importance of each subsystem, providing flowcharts and inspectional objectives for each subsystem.

There are two types of QSIT inspections: Level I Abbreviated and Level 2 Baseline. It is conducted qsti a firm has never had a Level 2 inspection, and every six years thereafter.

It provides an overall evaluation of fdz quality system. A Level 1 Abbreviated QSIT inspection is conducted after a firm has had a Level 2 inspection, and the quality system was found to be in compliance with all requirements. A different subsystem will be chosen for each subsequent Level 1 inspection.


Regardless of the type of inspection, it is up to you to always be prepared for FDA to visit your facility.

Understanding the types of inspections and possible inspection locations is just the first step. Make sure to sit down with your team and formulate a concrete plan for inspection readiness. Have a procedure available so employees know what to do and how to conduct themselves when an FDA investigator arrives at your facility. As always, an ounce of preparedness is worth a pound of remediation.

Peter Ohanian joined Halloran Consulting Group in He has more than 35 years of industry experience in medical device quality assurance and regulatory affairs. He has an extensive background establishing compliance programs and developing product clearance strategies. Prior to joining Halloran, Peter was the Vice President of Quality and Regulatory Affairs for Philips Healthcare, providing leadership and strategic direction for their patient monitoring and clinical informatics business.

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