Lowest Number of FDA Inspections Since 2008

FDAzilla has reported that the FDA conducted 39,774 inspections for the year ending 2013.

I guess on any given day, there are at least 109 auditing teams running around the world inspecting our GMP-regulated existence.

But it turns out that 39,774 inspections is a 5-year low for the FDA.  As FDAzilla puts it, this is the first time since 2008 that the FDA has dipped under 40,000 inspections per year.

Was it the government shutdown?  Was it the sequester?  Who knows?

As we ramp into prime inspection season (Q1/Q2 are known times when there's a lot of FDA activity), how are you guarding against getting dinged by the FDA?

• Inspect the (FDA) Inspector
• FDAzilla offer for Zymergi blog readers
• Buy 483 documents

FDA Is Conducting Fewer Inspections (Yayyy!)

by Oliver Yu

Zymergi's customers include large-scale biologics manufacturers: biotech companies that use cell culture or fermentation to make medicines. In the United States, biologics manufacturers are subject to regulations under Title 21 of the code of federal regulations, which authorizes the U.S. Food and Drug Administration (FDA) to inspect facilities.

Few take FDA inspections more seriously that biotech/pharma companies. Inspections are the path to facility shutdowns. Inspections lead to 483s. 483s lead to warning letters. Warning letters lead to consent decrees.

See FDA Inspections Funnel.

There appears to be relief for those in the regulated markets.  Data collected by FDAzilla (a Zymergi software licensee) shows that the FDA is conducting fewer inspections.  The number of inspections started declining in Q3 2012 and bottomed out in Q2ish 2013.
In fact, the FDA has conducted fewer inspections in 2013 than in any period in the 4-years prior.

It's not clear if biologics manufacturers have benefitted.  Just because the FDA is conducting fewer inspections does not mean that this decrease is impacting all areas (e.g. Food, Cosmetics, Tobacco, Drugs, Biologics, Devices...etc.) evenly.

Also, this decline in inspections appears to have little to do with the recent federal government shutdown:


That last bar (circled in red) is the shutdown.

Non-Essential FDA Inspections to Resume!

News reports indicate that the government shutdown is over.  "Non-essential" federal employees that were furloughed included FDA inspectors (euphemistically called, "Consumer Safety Officers").

Apparently, even the government admits that FDA inspections are... non-essential.

Regardless, I'm quite certain that the effect on the GMP operations around the world was that of pure joy. Inspection Readiness Teams could relax a bit.  Regulatory Affairs and QA managers didn't have to be on high alert (especially ones that hadn't been inspected in a while).

FDAzilla reports a significant drop in sales of 483 documents as RegA and Quality managers had no reason for last-minute research on the inspector that didn't show up (but will still collect backpay).

But now that paid vacation the furlough for FDA inspectors is over, it's time for the GMP community to get back on their toes and maintain inspection readiness.

Good luck.

Pareto Principle at work in Biotech

In the latest FDAzilla post, guest blogger and regulatory professional - Greg Hattoy - talks about 5 ways to prepare for a regulatory audit.

The first idea is that small things can build into big things and that management needs to have a pulse on what's going on. It isn't so much that there's something small out there that's wrong with your plant (like rust on the bottom of the fermentor) that that it becomes big (like your fermentor gets a hole in the bottom of it from the rust).

I've seen this in action where immediate- and short-term fixes are executed in a way that causes long-term maintenance chores. For example:

• The intended design of post-inoculation additions was among the suspect causes of bioreactor contamination.
• In the name of mitigating this potential risk via process of elimination, post-inoc additions were changed away from the intended design.
• True cause of microbial contamination was later deemed to be something else.
• Due to "don't fix what ain't broke" and heavy workload, the modified additions were never changed back.

You get enough of these decisions and a well-engineered plant encumbers itself and slips farther away from good engineering practices.

His second idea is that there are "Big Wins." This is absolutely consistent with the Pareto Principle where 80% of the effects can be explained by 20% of the causes, and though Greg states that it my fly in the face of the "small things add up" thesis, it actually doesn't. Here's why:

Every biotech professional from worker bee on up to the top of management has their list of 100 to-do's. Everybody is loaded down and their email inbox just looks like a constant scroll.

There actually aren't 100 different problems that need to be solved. It's actually something like 12 real problems. The majority of the effect/response (80%) is caused by a minority of the causes/factors (20%).

There are people who tackle this list according to priority: #1...done. #2...done. #3....done. And by the end of the day, the top 10 items get subtracted off the list (and another 10 get added).

Then, there are people who look at the list and go, "Gosh, #3, #7, #13, #49, #62, #85 are all related. If I spend time tackling the true root cause, I can hit six birds with one stone!" And when you go about solving problems in this manner, you can use the Pareto principle in your favor:

You can solve 80% of your problems by fixing 20% of what's wrong.

Obviously, there are times when you need to tackle the list sequentially. But this ought to be a minority of the time compared to tackling your to-do list strategically.

Critics of the sensible approach say that walking away from regulatory inspections has more to do with the personality of the inspector.  For that, there are ways of gathering regulatory intelligence.   But for the rest of us, following defensible plan is the most sensible approach for preparing for a regulatory audit.

FDAzilla 483 Deal for Zymergi readers

disclosure: FDAzilla uses Zymergi software.

We love promoting our associates, partners and customers (at least the ones who want to be promoted).

FDAzilla is a website that gathers intelligence on the FDA. They used our software to create the world's largest 483 store. The 483 themselves are redacted PDF files that list the inspectional observations:

If you have time, it's cheaper to go straight to the FDA and get these 483 PDF files. It'll take several weeks and you don't have any idea of the cost until the FOIA job is completed.

But if you value your time, your anonymity and your budget, here's why you go with their store:

• You can buy 483 inspectional observations instantly (otherwise, fill out an FOIA request and wait for an FDA rep to get back to you).

• You can buy the 483 reports anonymously (...other than the NSA knowing, of course).

• Every 483 is $119 a piece.

The FDAzilla Store and InspectorRank tool is especially good when an FDA inspector arrives onsite and you need quick access to the inspectional observations of this specific auditor.

Here's Megan Haggerty's 483 reports. And here's good ole Lance De Souza's 483 reports.

There's plenty of intel on these inspectors; but that also means you need to buy quite a few to get a good idea of the type of FDA inspector you have sitting in the conference room.

So for Zymergi blog readers, FDAzilla is offering the following discount code:

zymergi5

Use this zymergi5 discount code when you buy 5 or more 483 pdf documents and you'll get 16% off!