Frontier Biologics LLC – FDA Warning Letter, Mar 8, 2024

The FDA issued a Warning Letter to Mr. Justice following an inspection of their facility between February 27 and March 8, 2024. The company manufactures human amniotic fluid-derived product, Purified Fluid Allograft, and human amniotic membrane-derived product, Allograft Matrix.

The FDA determined that these products are unapproved new drugs, violating section 505(a) of the FD&C Act, and unlicensed biological products, violating section 351(a)(1) of the PHS Act. The products are intended for wound healing, inflammation reduction, or orthopedic use, classifying them as drugs and biological products. The Allograft Matrix product is also an HCT/P but fails to meet the homologous use criterion, thus not regulated solely under section 361 of the PHS Act.

The inspection also revealed significant Current Good Manufacturing Practice (CGMP) violations, rendering the products adulterated under section 501(a)(2)(B) of the FD&C Act. Violations include: 1. Failure to validate aseptic processes for Purified Fluid Allograft (21 CFR 211.113(b)). 2. Lack of validated manufacturing processes for both products to assure identity, strength, quality, and purity (21 CFR 211.100(a)). 3. Deficient environmental monitoring in aseptic processing areas (21