New FDA IntelliCell BioSciences, Audit Report: A Lot of Work to Do

IntelliCell BioSciences, Inc. of New York, a clinical stem cell establishment, has had a rough time of it lately.

For example, a recent piece of bad news is that there is an impending foreclosure sale of the company’s assets. What exactly that means for the company more broadly remains unknown, but a few people tell me (take this with a grain of salt either way) that the company is still seeing patients.

IntelliCell also has run into issues on multiple occasions including in 2012 with the FDA leading to a problematic audit report (called in biotech lingo a “483”; here) that identified 13 observations (aka “problems” in FDA lingo).

Then there was also subsequently a 2012 FDA Warning Letter.

FDA Warning Letters are issued for significant compliance issues.

The company was most recently inspected by the FDA in May-June of this year again.

How did that go?

Nobody knew really.

IntelliCell leader Dr. Steven Victor used a positive tone to talk about this year’s new FDA visit in a press release (emphasis mine):

“Our Company is very pleased that the FDA has inspected our new flagship cellular laboratory. While there are many companies and physicians’ practices in the cellular/regenerative medicine space that may attempt to avoid contact with the FDA, IntelliCell has adopted a more transparent approach. We will continue to work hard with the FDA to meet all cGTP requirements for the manufacturing of Human Cells, Tissues, and Cellular and Tissue-Base Products (HCT/P’s).”

Transparency is important. In that spirit, a month ago I asked Dr. Victor to release the FDA audit report from this latest visit, but no luck. I’m not surprised and of course he was under no obligation to do so.

However, the 2013 FDA Audit report of IntelliCell is available here now released by the FDA at my request (note that this is a fairly large PDF file; a screen shot of he top of page 1 is above).

While I cannot speak for Victor, if it were me, I would not have been very pleased to get this kind of report. The new 483 audit report details far more problems than last year, not exactly an encouraging trend in my opinion.

In fact 18 independent observations (many with numerous subsections) are detailed.

Does this mean that yet another FDA Warning Letter or some other regulatory action is in the works for IntelliCell?

The issues identified by the FDA in this new 2013 audit report, in my opinion, reflect an overall lack of key protocols and SOPs in place to document and protect patient safety from potential problems with the company’s stem cell treatments: infections due to potential lack of documented sterility, possible presence of bacterial endotoxin, and other issues. These kind of issues need to be addressed by any company selling stem cell treatments.

In addition, to my knowledge, the big issue of IntelliCell’s product being a biological drug of the kind requiring pre-review and approval by the FDA prior to administration to patients remains unresolved as well. In this new 483 report the word “drug” is used by the FDA numerous times.

It wouldn’t shock me if IntelliCell “regenerated” itself from these troubles and kept on operating clinically as a company, but it seems to me that the odds against that going on much longer get steeper each day. To be clear, I do not believe the problems in this latest 483 report are unsolvable or are in it of themselves devastating for the company, but they would require time, money, and dedication to address. I hope IntelliCell fixes the issues. I have emailed Dr. Victor to ask him a few questions about all of this.