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AlphaGEMS Micro

FDA judge amniotic

Federal judge blocks FDA action on Texas amniotic supplier

September 1, 2016 Paul Knoepfler 4

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 […]

Amniotic Therapies

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

August 31, 2016 Paul Knoepfler 15

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. […]

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