AlphaGEMS Micro

Federal judge blocks FDA action on Texas amniotic supplier

September 1, 2016 February 1, 2021 / By Professor Paul Knoepfler, Ph.D. / 4 Comments

The FDA issued a warning letter not long ago to Amniotic Therapies, LLC, a supplier of amniotic products including to one or more stem cell clinics, but now a federal judge in Texas has reportedly mostly blocked the FDA action in terms of the shutdown. The law firm representing Amniotic also issued a PR about the …

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FDA warning to Amniotic Therapies, LLC: impact on stem cell clinics?

August 31, 2016 February 1, 2021 / By Professor Paul Knoepfler, Ph.D. / 15 Comments

The FDA’s CBER branch recently issued a warning letter to Amniotic Therapies, LLC. The warning letter pertains to both AlphaGEMS-related products that are used by a number of stem cell clinics as well as problems determined at the manufacturing facility. I went to the Amniotic Therapies website, but perhaps not coincidentally it is down, which …

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