Class Action Lawyers Troll FDA Warning Letters

“Dr. Reddy's Laboratories Inc. is initiating this recall as a precautionary measure due to out of specification (OOS) results for the conductivity test for one of the excipients, Microcrystalline Cellulose (Avicel pH 102), NF supplied by DuPont.”

This letter was issued on October 1, 2021, and it was only the beginning of the bad news for DuPont Nutrition USA.

Backing up from here, DuPont Nutrition had recalled its Avicel brand Carboxymethylcellulose on Aug 27, 2021.  Why had DuPont recalled its Avicel? 

Well, as FDA notes in a Warning Letter, “Between April 2020 and June 2021, you received approximately 50 complaints related to your Avicel excipient failing to meet the conductivity specifications.”

FDA inspected DuPont on December 15, 2021 and issued them a Form 483 – a list of conditions which FDA investigators have observed during an inspection which they deem to be objectionable.

It gets worse.  In the meantime, International Flavors & Fragrances (IFF) was completing its acquisition of DuPont.  These recalls and other quality problems caused IFF to include them as a factor in its 2021 annual report to the Securities and Exchange Commission (SEC).

DuPont apparently did not resolve the issues that FDA pointed out in the Form 483, because a year later, on December 2, 2022 FDA hit them with a Warning Letter.  Warning Letters go up on the FDA website and they stay there for generations.

Now, if you look at the triggering incident, a “conductivity test OOS”, you might think it’s a pretty small thing which could have easily been overlooked.  However, read the actual Warning Letter, ~50 customer complaints, failure to validate analytical methods, improper sampling, inadequate change management, records, and data integrity – takes deep breath – and the mutha of all:  lousy CAPA. 

The message from FDA is that this was not a single point failure.  DuPont’s Quality System was a mess.

These are all things that stockholders want to know about, hence their inclusion in IFF’s SEC annual report.  Why?  Because they can cause a big hit on the bottom line.  BTW there is one even bigger hit to the bottom line than FDA action. 

Just google ‘Camp Lejeune water’ next time you’re doom scrolling – maybe you’ve seen the ads on TV.  If class action lawyers get wind that any of your customers might have gotten ill and there are GMP issues with your product, there will be blood in the water.

Class action lawyers troll FDA Warning Letters.

How about you?  Do you have a similar story?  What has worked best for you?  Comment below.