November 23, 2020

The Niche

Knoepfler lab stem cell blog

ICMS posts 483 report of FDA audit: still awaiting news on Celltex

The International Cellular Medicine Society (ICMS) is viewed somewhat skeptically by the stem cell community, but they are undeniably an important player in the stem cell world.

A few weeks ago I interviewed ICMS President, Dr. Ricardo Rodriguez  (see interview here), and then I provided recommendations here to the ICMS to improve their organization including a less adversarial relationship with the FDA amongst other recommendations that include a patient resources webpage and an outside advisory committee.

ICMS more recently announced in a PR that its IRB has been audited by the FDA.

Now ICMS has gone a step further in an encouraging sign of transparency and publicly posted the FDA report (called a 483) from the audit. You can read it here (PDF). The audit took place over 4 days according to the 483.

It’s fascinating reading. ICMS also posted a PR on the audit.

The FDA made 8 observations about ICMS and most of the observations were broken down into subsections as well. These observations, to paraphrase the FDA website, are basically things the FDA views as “objectionable”.

What are the FDA concerns?

There are quite a few, but generally the concerns point toward the FDA wanting ICMS to more strictly govern how it runs its IRB. I am not a regulatory expert but it seems to me that “Observation 1” may be the most significant (see below). I’d value other input from the blog readers on the 8 observations.

ICMS IRB FDA letter screenshot.

In the ICMS PR about the audit they make a number of statements about the FDA and the practices of the ICMS. Executive Director, David Audley is quoted as follows in the ICMS PR:

“While we have not yet received the final report from the FDA, we are very pleased with their initial conclusions.” stated Audley. “The FDA’s comments were limited to relatively minor issues such as increasing the level of detail in meeting minutes and providing a clearer explanation of the relationship of reviewers to the ICMS. We expect to be fully compliant with the recommendations of the FDA by August 1, 2012.”

At this time there is still no news from the FDA regarding its reported visit to Texas stem cell firm, Celltex, and Celltex itself is mum, but I’m thinking we should hear something about that pretty soon. Grapevine on this remains mixed as to the outcome….stay tuned!

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