“Forget about actual warning letters. The cost of us receiving a moderately bad 483 is roughly $250,000.”
I heard this from a reputable Head of Manufacturing of one of the largest biopharma companies in the world. While most pharma and med device companies seems to learn quickly from everyone else’s mistakes, companies still occasionally get a “moderately bad” 483. And then what happens after that? Continue reading →
FDA and the EU have taken serious enforcement actions against several firms in the others geographic jurisdiction in calendar year 2016. Perhaps this flurry of my-inspectors-are-more-rigorous-than-yours type represents an unofficial test of sorts as these two agencies move to rely more on each other’s inspections. These inspections may test the limits and validity of the underlying assumption that would permit this mutual recognition. Also interesting is that the European inspections specifically evaluate investigational product manufacture, something FDA does not generally do except on a for-cause basis. Below we cover the three EU reports of GMP non-compliance issued regarding sites in the US and three FDA warning letters, one FDA import alert, and one untitled letter issued regarding sites in the EU.
Due to popular demand, we have decided to add EIRs into our store. Establishment Inspection Reports (EIRs) are an important tool in your tool belt of inspection preparation and intelligence. If you aren’t familiar with them, read our recent post on the 5 Things to Look for in an EIR. Continue reading →
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:
Over the years, the FDAzilla blog has published almost 300 articles. We’ve acquired a lot of new readers since we started writing here in 2010. With these newer followers in mind, FDAzilla has assembled a list of some of our most useful articles. To put together this collection, we considered which posts have been the most searched-for and viewed over time, and evaluated these popular posts for helpfulness and continued relevance.
We hope this compilation will serve as a resource for you and your company. It should also help orient you to the scope of the FDAzilla blog as you continue to follow our efforts to provide accessible FDA data and insights. Continue reading →
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 →
Times are changing. We now live in a world where we have too much information and way too much raw data, but not enough wisdom. More and more often, a lot of answers isn’t as useful as one good question. Isn’t the same true for our field of inspection preparation and regulatory intelligence. Why can’t we apply new data and word analysis technologies so that our teams can more effectively reach our quality goals? That’s where we’re headed at FDAzilla. Continue reading →
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:
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 Guidanceon 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.
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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 →