Tag Archives: fda inspection

  • 483 Audit Forms

    … should not go unnoticed. A 483 audit is issued after the conclusion of an fda inspection. This form states that certain conditions were cited as “in violation” of FDA standards/regulations. The FDA investigator feels that the practices or conditions surrounding the product at hand is in question and therefore a change needs to be set forth, in order for operation to continue. A company must understand the problem at stake as well as the violations that are in play as a way to avoid an …

  • New Data on the Inspection of Human Cell & Tissue Products by the FDA

    A recent report charting inspectional information by the FDA for human cell/tissue therapeutic products shows a marked increase in inspection activity. The period covered is 2003-2010 and reports an increase in the number of inspections by about 250%, with an average duration of each inspection of 40-45 hours. During that period, voluntary compliance actions taken by companies as a result of inspections has increased 255% and official action taken has increased 240%. This is against a background …

  • FDA Inspection Wizard: What’s Scary Can Turn Out to Be a Piece of Cake

    Although fda inspections of clinical sites are not an indictment of something being wrong with a clinical site, it can nevertheless still be a scary experience, especially if you are not properly prepared. An fda inspection is basically a quality assurance process that is used to confirm clinical data management/integrity and regulatory compliance.  Here we show you how to make it a piece of cake for your site and your nerves. Kinds of inspections -The most common fda inspection is the …

  • How to Get Through a Successful Pre-Approval Inspection

    If your company is associated with the pharmaceutical industry in any way, whether it be manufacturing, supplying, or research and development, there’s a pretty good chance that your company will be audited with some kind of fda inspection down the line.  When by chance, your company is audited, they will have to pass a series of fda inspection tests, to ensure that your company is running in compliance to FDA standards, and that all your research and manufacturing information can be …

  • Failing an FDA Inspection

    … problems to your company in the event of an inspection failure.  Here are some consequences your company might face if you fail your fda inspection. One severe consequence of this is that the news will very likely become public, which could damage your reputation as a company.  This may result in a loss of consumer confidence, your stock prices could very well go down, and your business partners and investors may lose faith in your company.  This could result in millions of lost investment, …

  • How to Prepare Your Company for an FDA Inspection

    Preparing your company for an fda inspection is no easy task, but if you do all the adequate preparation necessary and know all the key points your company will be inspected on, your company has a much better chance of success.  Like it or not, if your business is involved in any way with the FDA, sooner or later, your company will face inspection.  If your company is not adequately prepared your company or its products can be seized, penalized, or even brought up on charges. Instead of …

  • Be Prepared When the FDA Knocks on Your Door

    … way to ensure a successful fda inspection is to ensure the facility complies with FDA regulations.  Every employee must be aware of the products and processes’ FDA standards for the area he or she tends to.  Employees have to be trained to stay calm, be respectful, and follow the FDA official’s requests, as well as to know their rights about what they have, or not have, to say or show the FDA. 2.    Identify and work on weaknesses Smart professionals work on identifying the weaknesses …

  • Regulatory Inspection Readiness

    … initial mock testing is completed.  Creating an accurate and thorough system is key to develop an effective regulatory training system, which will help your pharmaceutical company to pass any fda inspection every time. If you liked this article, tell all your friends about it. They’ll thank you for it. If you have a blog or website, you can link to it or even post it to your own site (don’t forget to mention www.smartconsultinggrp.com as the original source. Don’t Forget to Subscribe …

  • FDA Regulations

    … companies wouldn’t be able to pass a simple FDA regulatory inspection if they had to.  If you want your company to be properly prepared, talk to a pharmaceutical consulting firm that specializes in quality control, and they will be able to prepare your company properly in case of a surprise fda inspection in your company’s future. If you enjoyed this article, please feel free to post it to your site or blog and forward this link to your friends. Have a great day! Don’t Forget to …

  • How to Prepare Your Company for FDA Audits

    Like it or not, if your business is involved with the FDA in any way, sooner or later, you will run into an inspection.  A surprise audit.  And if you’re not prepared, your company could be seized, penalized, or even brought up on charges.  Getting an fda inspection is no small thing, but if you make the right preparations your successful FDA audit will become a reality. One of the first things you want to do is prepare yourself and your company.  If the inspection is happening next week, …

  • What If You Fail The FDA Pre Approval Inspection?

    Failing an fda inspection is not the end of the world, but it can sure bring on a lot of trouble for you and your company. Either because of recklessness or because you did not prepare enough for the inspectors’ visit.  Failure at this stage will make the FDA doubt if your method of analysis and the way you plan to manufacture your product are as you claim, “the best”. If after reviewing the submitted information and establishing detailed specifications for manufacture and control of your …