CDRH QSIT Team Considers Third-Party Audit Option To Level 1 Inspections
This article was originally published in The Gray Sheet
Firms with a good compliance history may be eligible to submit third-party auditing certifications in lieu of biennial FDA inspections, according to a proposal being drafted for consideration by the Center for Devices and Radiological Health's quality systems inspection technique (QSIT) reengineering team.
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Quality systems inspections of device manufacturers between Oct. 1, 1999 and Jan. 1, 2000 will employ either traditional or Quality Systems Inspection Technique (QSIT) methods, depending on inspector training, FDA officials report.
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