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Amnio Technology, LLC manufactured and distributed amniotic membrane and amniotic fluid-derived products (PalinGen® Flow® and PalinGen® InovōFlo®) with claims that they promoted wound healing and tissue regeneration, thereby classifying them as drugs and biological products requiring FDA approval. The company's promotional materials made therapeutic claims about growth factors, anti-inflammatory properties, and regenerative capabilities without proper regulatory authorization. The FDA inspection conducted in August 2022 at the company's Phoenix, Arizona facility and storage/distribution site documented significant deviations from current good manufacturing practices and regulations governing human cells, tissues, and cellular products (HCT/Ps).