Amnio Technology, LLC

Warning LetterOpen

Merrill B. Stromer Chairman Amnio Technology, LLC 22510 N. 18th Drive Phoenix , AZ 85027-1363 United StatesFEI 3011545418Issued Oct 1, 2024Center for Biologics Evaluation and Research (CBER)

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3011545418.

Violations7

Issue DateOct 1, 2024

Product TypeBiologics

StatusOpen

Letter Details

Firm: Amnio Technology, LLC
Location: Merrill B. Stromer Chairman Amnio Technology, LLC 22510 N. 18th Drive Phoenix , AZ 85027-1363 United States
FEI Number: 3011545418
Country: United States
Issue Date: October 01, 2024
Issuing Office: Center for Biologics Evaluation and Research (CBER)
Product Type: Biologics
Status: Open

Summary

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).

Amnio Technology, LLC FDA Warning Letter, October 1, 2024