FDA WARNING_LETTER - Amnio Technology, LLC - August 29, 2022

The FDA issued a Warning Letter to Amnio Technology, LLC, following inspections from August 15-29, 2022, at their Phoenix facility and a storage/distribution site. The letter addresses the manufacture and distribution of PalinGen® Flow® (amniotic membrane and fluid derived) and PalinGen® InovōFlo® (amniotic fluid derived) products, marketed for wound healing and tissue regeneration.

The FDA determined these products are unapproved new drugs and biological products, violating sections 201(g)(1) and 505(a) of the FD&C Act and 351(i) and 351(a)(1) of the PHS Act. PalinGen® Flow® is also an HCT/P that fails to meet minimal manipulation (21 CFR 1271.10(a)(1)) and homologous use (21 CFR 1271.10(a)(2)) criteria, thus not regulated solely under 361 of the PHS Act. PalinGen® InovōFlo® is not an HCT/P. Neither product has an approved Biologics License Application (BLA) or an Investigational New Drug (IND) application.

Significant Current Good Manufacturing Practice (CGMP) deviations were also cited, including: 1. Failure to validate manufacturing processes for identity, strength, quality, and purity