Home > Newsletters > The QMN Weekly Bulletin > Prosec Protection Systems Handed 483 for Process Validation Lapses
The QMN Weekly Bulletin
June 15, 2012 | Vol. 4 No. 24
Prosec Protection Systems Handed 483 for Process Validation Lapses
Prosec Protection Systems, a maker of umbilical clamps, received a Form 483 for various process validation deviations at its Lakewood, N.J., plant.
Prosec, also known as McRoberts Security Technologies, does not test its clamps for assurance of stability, nor does it accurately interpret, document or review its sterility testing procedures prior to shipment, the form states.
Sterility cycle reports are supposed to be reviewed and approved, but numerous cycles passed in 2011 without such reviews or approvals, FDA investigators said.
Lakewood staff also broke from company protocol on sterilization validation runs. For example, a final validation report for an interim run that failed for “temperature out of range” provided no rationale for not running consecutive cycles. The failure also was not investigated or evaluated, according to the form.
What hotspots in your operation could prompt an FDA inspector to issue you a Form 483?
You can wait until the inspectors arrive to find out. Or, you can jump ahead by learning exactly what’s triggering citations in other companies and fixing your similar vulnerabilities before the inspector arrives.
Start now … with access to the actual Form 483s being issued to companies just like yours. From FDAnews, Form 483 Watch: Medical Devicemaker Inspections in the News.
In one convenient source, this report provides an authoritative reference collection of the most newsworthy Form 483s issued recently to device manufacturers, including insights and analysis on what the inspections mean regarding everything from quality assurance to your relationships with service providers.
Don’t wait another moment to get this powerful tool in the your team’s hands. Order today.
ePublishing :: CMS, Hosting & Web Development | © Copyright by FDAnewsAll rights reserved. Do not duplicate or redistribute in any form.