We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Home » Inadequate Review of Contract Sterilizer Leads to Form 483
Inadequate Review of Contract Sterilizer Leads to Form 483
Retractable Technologies’ device history records do not include a cycle chart for part of the sterilization cycle used by one of the company’s contract sterilizers for 1cc and 3cc VanishPoint syringe product lines, according to a recent Form 483.
To View This Article:
Login
Subscribe To The GMP Letter
The GMP Letter Subscription
The GMP Letter (GMP) to stay on top of the FDA's interpretation and enforcement of the quality systems regulation and to learn which changes they must make to stay in compliance. In each monthly issue, you get an update on key regulatory developments, tips on how to prepare for FDA inspections, proven ways to improve design control procedures, ideas to create more effective GMP training programs and more.
With a subscription to The GMP Letter, you’ll get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.
Each issue provides:
New and draft FDA guidances;
Implications of new regulations
Reasons/causes for the most recent warning letters;
Updates on key regulatory developments;
Tips to prepare for FDA inspections;
Proven ways to improve design control procedures; and
Ideas to create more effective GMP training programs.
There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with The GMP Letter, you may cancel your subscription and receive a full refund. No questions asked.
So, why wait? Become a subscriber to The GMP Letter today. It couldn’t be easier.