Resources

Today we have the privilege of interviewing former FDA investigator, LuisChavarria. After 30 years of conducting, managing, and supervising inspections, his insights are worthy of heavy consideration. 1. What do you think are the biggest misconceptions about FDA inspectors? I believe the biggest misconception about FDA inspectors is that they are there to “get you.” […]

We at FDAzilla are officially calling it. August is FDA Form 483s month. For the next 30 days, we will be posting a new article about FDA 483s every weekday – from insider insights to former investigator interviews to news synthesis to new data. As we’ve mentioned before, the FDA 483 is going through a […]

If you could ask the FDA anything about 483s or inspections anonymously, what would you ask? We’ve been in talks with the FDA, and it’s highly likely that they will be willing to answer a list of thoughtful questions from us. As the 483 has received increasing attention, it is in everyone’s best interest to […]

The first part of the month was relatively quiet, but then things really start hitting the fan last week.  Here are some of the latest stories related to FDA 483s: Of course, the big story of the month is Ranbaxy.  FiercePharma reported that it may have been a 483 that explains why Ranbaxy did […]

The FDA is watching you. Let FDAzilla help you watch them. We’ve talked to a lot of people who are seeing increased attention on FDA 483s. Industry professionals are looking to gain an edge as they prep for their next FDA inspection and to size up competitors and/or potential partners.Reporters are increasingly referring to specific […]

Here’s 10 recent stories that have hit our radar related to FDA 483s: FDA GMP inspectors cite 70% of dietary supplement firms within 3 years.   Frankly, I’m surprised that it wasn’t closer to 90%.  Average number of FDA 483 observations – 7. Impax hires 3 gurus to fix their manufacturing woes. A little unusual, […]

Now I know why we’ve been getting more calls/emails from financial institutions and hedge funds inquiring about FDA 483s – more and more investors are being introduced to the term during investor calls. While technical in nature, digging through a company’s history of 483s – especially when compared to competitor company’s profiles – can uncover […]

At a time when FDA’s responsibilities continue to grow rapidly, the agency has been caught in an across-the-board reduction (sequester) in federal discretionary spending, effective March 2, 2013. Although Congress may yet reverse course and restore money to affected federal agencies, this is not considered a high probability. Altogether, FDA will lose about $209 million […]

FDA is the only federal agency that touches the lives ofeveryAmericanseveraltimeseveryday. Despite this, FDA will probably not be mentioned when President Obama delivers his State of the Union (SOTU) address to Congress on February 12. Instead, FDA Matters provides its third annual “State of the FDA.” As reflected in last week’s column, I think that FDA did well […]

Just like great football coaches watch film of opposing teams, we have to watch what the FDA is doing – learn their tendencies and habits. One of the best ways to do that is through our film – the FDA 483. Need a quick refresh? Here’s a great list of 20 web-based (mostly free) resources […]