FDA WARNING_LETTER - Pinnacle Transplant Technologies, LLC - August 29, 2022

The FDA issued a Warning Letter to Pinnacle Transplant Technologies, LLC, following an inspection from August 15-29, 2022. The inspection revealed that their products, PalinGen® (b)(4) (amniotic membrane and fluid derived) and PalinGen® (b)(4) (amniotic fluid derived), distributed as sterile and intended for therapeutic uses like wound healing, are unapproved new drugs and biological products. PalinGen® (b)(4) is also an HCT/P that fails to meet minimal manipulation and homologous use criteria (21 CFR 1271.10(a)), thus not regulated solely under PHS Act section 361.

The company lacks an approved Biologics License Application (BLA) or New Drug Application (NDA) for these products, violating sections 301(d) and 505(a) of the FD&C Act and 351(a)(1) of the PHS Act.

Significant Current Good Manufacturing Practice (CGMP) deviations were identified, including: 1. Failure to validate aseptic processes for sterile products (21 CFR 211.113(b)). 2. Inadequate laboratory controls and finished product testing (21 CFR 211.160(b)). 3. Failure to investigate 8 sterility failures between July 2020 and