Just a quick update – the FDAzilla Enforcement Analytics database was updated with data through April 25, 2017. We typically refresh the inspections data every 3 weeks or so, pair new warning letters with inspections every week, and add new 483s, EIRs, and 483 response letters every month.
The FDA has been writing up companies on data integrity since the year 2000. Even after all the horror stories, and even after billions of dollars of market cap have been erased from it, here we are in 2017, still talking about it.
Here is some troubling text from recent Warning Letters that cite data integrity:
“…our investigator observed your warehouse supervisor tearing out pages from your firm’s annual report and placing the pages into his pocket.”
New data synthesized by FDAzilla has revealed several dramatic shifts with FDA inspection and enforcement activity.
The FDA issued 15 pharma GMP-related warning letters to manufacturing sites in China in 2016 – a 5-fold increase from years prior. China averaged 2.7 Warning Letters per year from 2013 to 2015. This explosion was led mostly by infamous FDA investigator, Peter Baker, who performed 17 inspections in China in 2016, leading to 13 FDA Form 483s and 4 Warning Letters. Continue reading →
Preparing for GMP inspections, particularly pre-approval inspections, can be a challenge when resources are limited and staff may have little expertise in these important activities. This becomes especially complex for start-up companies that are virtual, or essentially virtual, and rely on contract manufacturers and contract laboratories. Virtual firms are responsible for the content of the submission, release of product to the clinic or for commercial distribution and post approval safety reporting even though they may not manufacture API or dosage form. The following are some suggestions for these firms to ensure a successful inspection outcome when they have limited experience in this activity and limited resources:
Surveillance, analysis and communication of regulatory and GMP intelligence has evolved over the past decade. The individual(s) tasked with this activity within pharma companies require broad experience in regulatory affairs and GMP compliance. The individual(s) must have sufficient historical perspective to compare and contrast new requirements with those they replace and to compare requirements and expectations among the major health authorities. It is no longer sufficient to simply summarize new or revised requirements but rather it is necessary to provide the added value of determining how the new requirements may affect the firm’s operations.
What industry news have you been reading this month? At FDAzilla, we’ve compiled the most noteworthy articles we’ve come across in the weeks since our last update. This month’s picks include information from two conferences, surprising warning letters abroad and in the US, an explanation QSIT protocol, and stories of both exemplary and reprehensible strategies from companies dealing with in-house deficiencies. Take a look:
A consent decree agreement is an agreement filed in the US courts formalizing a voluntary agreement between two parties. Here we will address consent decree agreements between FDA and several pharmaceutical companies based on repeated failures to adequately address CGMP deficiencies. It is not an action taken on the basis of a single form 483, or a single warning letter. Generally, a series of events play out over time when critical inspection observations are not addressed and are identified in subsequent inspections. Frequently one or more warning letters are involved. Consent decree agreements often include fines, with the option for additional financial penalties if conditions to which the firm agrees are not met. Often these firms are required to use a 3rd party consultants to perform lot release. Firms operating under a consent decree agreement have largely lost their independence in GMP activities. Unlike Corporate Integrity Agreement which have a defined duration, firms must petition to have the consent decree agreement condition rescinded.
If you haven’t been to FDAzilla.com in a while, then you’ve come to the right place. If any part of your job involves preparing your company for FDA GMP inspections, let me take you on a quick tour of some tools and resources that you might find useful! Take 4 minutes and check out these 4 things:
“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 →
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 →
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.