What does it even mean to officially respond to a 483 and, better yet, how can a 483 be avoided altogether? The answer is basically split into 3 parts that we dive into in this post.
Okay, let’s settle this once and for all. We wrote a series of posts that will give you an industry primer for what these Form FDA 483s are, why they’re important, how to avoid them, and how to respond to them. Today, we cover the basics. Some of you pros out there know this stuff all too well…
“As FDAzilla continues to grow, we believe we must do our part - locally and globally - to do good by doing well.” Tony Chen (one of our co-founders) shares this unique story of who we really are at FDAzilla.
I spoke to a former VP of quality at the PDA/FDA Joint Regulatory Conference. He said one of his bad 483s probably cost him $5 million. And that’s cheap – that’s just a 483. What about a warning letter? There is an even greater magnitude of reputation damage, impact on new drug approvals, etc. This post describes the full scope and includes articles/case studies.
Form FDA 483s are central to anyone’s FDA inspection preparation program. As the keeper of the world’s largest database of FDA 483s, we often get asked, “How do you get a hold of actual 483 reports and who else can see them?” This is where things get a little tricky. Theoretically, Form FDA 483s are public information and, thus, [...]
About 3 months ago, I decided to take a deeper dive into Artificial Intelligence (AI). I've previously written about why and how I'm going to do so, and even coded my first neural network. While AI has been overhyped in the media, it does represent a game-changing technology that will make its way into every industry. As such, how will [...]
Here at FDAzilla, we’re excited to report that we have just collected our 20,000th FDA Warning Letter, going back to 2000, all completely searchable in our database. As you may know, the FDA automatically archives warning letters older than 5 years (and just did so with their 2012 collection last month). Yes it’s true: arguably, the older the warning letter, the [...]
I'm thrilled to announce that Michael de la Torre is FDAzilla's new CEO, effective October 19, 2017. He comes to us after an already-amazing run in executive roles at several companies - leading large teams, collaborating with customers, and expertly scaling businesses. Feel free to connect with him at michael@FDAzilla.com or on LinkedIn. Read the press release here. I will step down from all my CEO duties, though you will [...]
We took a snapshot of the 5 warning letters the FDA sent to pharmaceutical companies last month. Drug manufacturing violations ranged from sites failing to establish adequate quality control to failing to label products to bear adequate directions for use. From pharmaceuticals in China, New Mexico, and more, here they are (starting with the most recent): […]