Benjamin Franklin said, “By failing to prepare, you are preparing to fail.” Prepare for your FDA inspections with Establish Inspection Reports (EIR). An EIR is the full report of an FDA inspection written by the investigators. Among the features identified in the report are:
I asked Barb Unger a difficult question, “If you could just pick 6 483s to understand this Data Integrity problem, which 6 would you pick? And why?” Here is her response.
As we continue to follow the data integrity story, let’s take a look at six (6) forms 483 associated with data integrity that had broad impact throughout the industry or resulted in serious enforcement actions including consent decree agreements. You will see that they are not limited to a single country and many of the observations are similar or exactly the same over a decade. Continue reading
If part of your job involves preparing for inspections or analyzing FDA cGMP inspection trends, you should watch this video:
Any questions? Want to get a live demo for you or your team? Contact Ben Anderson at ben@FDAzilla.com.
5 FEATURES TO LOOK FOR IN A WARNING LETTER
Warning letters are the FDA’s second level of enforcement actions after issuance of a form 483. The FDA determined that either the firm’s response to the form 483 was inadequate or the observations were serious enough to support issuance of a warning letter. Often it is possible to determine the corrective actions necessary and the impact that the warning letter will have on the business. To determine a letter’s impact on the business, I ask these questions:
5 FEATURES TO LOOK FOR IN AN FDA FORM-483
A form-483 is the document that FDA issues at the close of an inspection where they identify observations made during the inspection. If no observations have been made, no form 483 is issued. Based on the response submitted by the firm, FDA classifies the inspection as: No Action Indicated (NAI) when no form 483 is issued, Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). In general, where FDA issues a form-483 with observations and the firm’s response is satisfactory, the inspection is classified VAI.
The FR announced availability of the long awaited 10-page FDA draft Guidance on Data Integrity and Compliance with CGMP for comment. I include links to the MHRA guidance HERE and the draft WHO guidance HERE for comparison. The guidance is structured in a Q&A format with a total of 18 questions. This guidance focuses heavily on identifying and citing the predicate rules as they apply to electronic records and data integrity, and for this it is an excellent reference. In my opinion, though, the excessive citation of regulations detracts from the content and provides little insight into FDA’s intent and actual expectations in this area.
by Barbara Unger, FDAzilla GMP Quality Expert
INDIA | IMPORT ALERT 66-40 and Association with Warning Letters Regarding These SitesDetention Without Physical Examination of Drugs from Firms Which Have Not Met Drug GMPs
As we’ve written extensively about the infamous Form FDA 483 here at FDAzilla, we’ve decided to make it easier for you. Here, we’ve created a centralized list of the 7 best resources to go from Joe to Pro on understanding Form FDA 483s. Continue reading
Lots of people are talking about our new data analytics tool that provides insights and intelligence into FDA inspectors, inspections, 483s, and warning letters.
Here’s an introduction to Enforcement Analytics
What do you think about this infographic? Have ideas for future infographics? Post a comment below or email email@example.com. Continue reading
Barbara Unger has shared about the new regulatory expectations regarding GMP Regulatory Intelligence. Indeed, we have heard that FDA inspectors have started asking people about what processes they have in place to monitor new regulations, guidelines, and developments. In part, this is why we offer the GMP Regulatory Intelligence newsletter.
Now, we go deep into a serious issue that has received a lot of attention and press – data integrity. I’d venture to guess that billions of market capital has been lost because of this one issue. The crazy part is this – it’s not even close to being a new issue. As you’ll see, the data integrity story began at least 15 years ago. Continue reading
I was intrigued by a recent conversation I had with Barbara Unger, the editor-in-chief for GMP Regulatory Intelligence. It’s becoming increasingly clear that the FDA wants to make sure you have a rigorous process to stay updated about the latest regulations and guidelines. Here’s what she had to say: Continue reading