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Pinnacle Transplant Technologies manufactured amniotic membrane and amniotic fluid-derived products (PalinGen®) marketed for wound healing and other therapeutic uses, which the FDA determined were drugs, biological products, and human cell/tissue products (HCT/Ps) subject to 21 CFR Part 1271 regulation. The inspection conducted in August 2022 identified that Pinnacle failed to comply with HCT/P regulations, though the specific regulatory deviations are redacted in the available letter excerpt. The company distributed these products nationally to third-party distributors, private label partners, and directly to healthcare facilities, representing a widespread compliance concern for products intended to be sterile.