October 24, 2020

The Niche

Knoepfler lab stem cell blog

Intellicell Inspected By FDA: What Does It Mean?

IntellicellIntelliCell (SVFC) is a stem cell company that does cosmetic stem cell procedures. They’ve had a number of challenges of late including an FDA warning letter about a year ago and apparent financial issues manifesting in lawsuits.

Now the company itself, perhaps trying to get ahead of the news, issued a press release (PR) saying they were inspected by the FDA for 3 weeks recently. A typical FDA visit lasts 2 weeks during which time the FDA inspects documents, procedures, and such. It is unclear why this visit lasted 3 weeks.

The PR says the FDA made “observations”, which are in essence major concerns:

The observations from the FDA inspection were provided to the company in the Form 483. The Company will respond to those observations in a timely manner. IntelliCell will take the necessary actions to address the relevant FDA observations.

Chairman and CEO, Dr. Steven Victor (aka Dr. LookGood, dermatologist to the stars) gave his reaction in the PR:Dr LookGood

“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).”

In general experts say that no one is pleased to get a visit from the FDA and it is a very stressful, complicated experience to be audited by the FDA. I’m glad that Victor says he has adopted a more transparent, working relationship with the FDA and the public.

Yesterday (June 19), I emailed Victor asking in the spirit of that “more transparent approach” he mentions in the PR for a copy of the 483 form. Let’s see if he follows through on the promise to be more open.

I wonder what the FDA observations were? Minor things? Major things? How many? The answers to these questions will bear greatly on the company’s future.

Since the warning letter and now the inspection, I also wonder if IntelliCell is still selling and providing stem cell interventions to patients, despite the concerns already raised by the FDA?

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