How Does the Government Shutdown Impact FDA Inspections?

Half Open, Half Closed

The government is still shut down, though the FDA is still about half-open.  The question is: which half?

The government shutdown is now on day 9, with no end in sight. Based purely on our 483 sales data in the last 9 days compared to September data, we’re seeing a significant drop. It makes sense that FDA inspections have either slowed down significantly or stopped completely. It was reported earlier this week that 45% of the entire staff would be off. Continue reading

FDAzilla mentioned on front-page WSJ story

wsj mention

FDAzilla was mentioned in a front-page story today in the Wall Street Journal.  The article mirrors a key theme that we’ve talked about here – that the investment community is becoming more and more interested in FDA 483s, FDA inspections, and other government data.

Current and potential investors of your company may actually be reading your FDA 483.

Read the whole article here>> Continue reading

Ranbaxy gets hit by FDA again

Ranbaxy_Logo.svgRanbaxy stock took a 30% hit today following an import alert issued by the FDA. The alert was reportedly issued based on serious cGMP issues at the Mohali plant from September and December 2012 483s.  Ranbaxy’s other two plants in India were already barred from importing to the U.S., this third plant in India was supposed to be the model plant, paving the way to a recovery. Obviously, this is a huge blow to the company.

For more context on Ranbaxy’s tumultuous year, read FiercePharmaManufacturing’s write-up.  FDAzilla has the September 2012 FDA 483 available for immediate purchase and download in the FDAzilla store.

 

 

2,300+ FDA 483s now available in the FDAzilla store

Screen shot 2013-08-20 at 9.12.25 AMBy popular demand, we’re excited to announce that we have recently more than doubled the size of our 483 library. After painstakenly obtaining, organizing, renaming, and categorizing these documents, we now have 2,300+ 483s and counting in our library available in PDF format for immediate purchase and download. Continue reading

5 Ways to Prep for A Regulatory Audit: A Holistic Approach

Greg HattoyToday’s post is written by guest blogger Greg Hattoy.  Greg is a regulatory compliance specialist and insightful industry writer at his blog, greghattoy.com. Greg takes a distinct approach to regulatory issues and shares his innovative vision for the direction of the pharmaceutical industry

As a regulatory professional, lately it has becoming glaringly apparent that the only way to be successful in a regulatory audit is to take a holistic approach to quality. Holistic can be simply defined as ‘emphasizing the importance of the whole and the interdependence of its parts’. Like holistic medicine, for a ‘healthy’ status with the regulatory agencies, a company, with all their individual components, must be firing on all cylinders in regards to compliance with the greater goal of quality. Now I fully understand this may sound like hippie nonsense, but before the incense candles, spirit crystals, and kumbaya songs come out, let me further explain this thought. Continue reading

The Most Famous QA/RA Blogger Just Revealed His Identity

QAPharm_1

I started the QAPharm Blog three years ago as a creative outlet to share my perspective on the pharma industry and the quality assurance profession. I have appreciated my faithful readers from dozens of countries around the world.

For years, we’ve been following The QA Pharm Blog. Writen with an equal dose of deep industry expertise, refreshing transparency/voice, and wit, we’ve all wondered – who is this masked man? Continue reading

Everything you’ve ever wanted to know about how FDA 483s are written

We receive a lot of questions, especially from our international colleagues, about how FDA 483s are actually written – the whole “lifecycle”, if you will.  Based on manuals and other FDA resources that are publicly available, we answer your 10 most frequently asked questions in this area. Especially if you are new to FDA 483s, this is for you.  For the seasoned among you, this is a good review. Continue reading