Abbreviated FDA Inspections Outlined In Draft CPG For Auditing Program
This article was originally published in The Gray Sheet
Executive Summary
Medical device facilities should receive a comprehensive quality system inspection every six years "as district resources permit" with "abbreviated" inspections in between, according to a draft FDA compliance program guidance (CPG) on auditing device manufacturers.
You may also be interested in...
"Minor" Infractions Will Not Trigger Warning Letter Under Final CPG
FDA inspections that uncover "minor nonconformities" with a company's quality system regulations (QSRs) will not draw regulatory follow-up action under the agency's soon-to-be-published final compliance program guidance (CPG) for medical device audits.
"Minor" Infractions Will Not Trigger Warning Letter Under Final CPG
FDA inspections that uncover "minor nonconformities" with a company's quality system regulations (QSRs) will not draw regulatory follow-up action under the agency's soon-to-be-published final compliance program guidance (CPG) for medical device audits.
CDRH QSIT Team Considers Third-Party Audit Option To Level 1 Inspections
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.