Not all FDA inspections involve large manufacturers, but that doesn't mean that they are not important.
Take the recent inspection of a New York company that takes recovered fat from patients, treats it and then injects it into them for an off-label procedure for cosmetic treatments. It has received an FDA warning letter and a form 483 for, among other things, failing to properly test its products.
The FDA found that IntelliCell Biosciences in Manhattan, which is not licensed for working with biologics, is recovering and processing "ipoaspirate into stromal vascular fraction known as IntelliCell antidipose-derived stem cells. The IntelliCell product is administered to patients intravenously, (b)(4), or is injected into specific areas of the body, such as the lips, cheeks, knees, scalp, and/or buttocks."
The product is promoted in a YouTube video that claims the product can be used "off-label to treat various patient ailments." It further explains that the IntelliCell product can be used to treat wrinkles, osteoarthritis, and gum recessions--even breast augmentation.
But the FDA says that the IntelliCell process alters the tissue in such a way that it does not meet even minimal standards. And using it for osteoarthritis and gum recession doesn't meet "the definition of homologous use." The FDA determined the product violated both the Federal Food, Drug, and Cosmetic Act and Public Health Service Act.
On top of everything else, the company is not appropriately testing or rejecting products that don't meet standards and did not have proper procedures for cleaning equipment.
The FDA first agreed to an extension for a response but then rejected the company's requests when it asked again.
- check out the FDA warning letter
- here's the YouTube video
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