Amnio Technology, LLC — FDA Warning Letter Findings

Your response to Observation 6 states, “We have added specific testing into our SOP’s ( sic ) that instructs the tests needed to be performed are HIV, Hep B, Hep C, HTPE, Creutzfeldt Jacob (sic) Disease, and communicable disease risks associated with Xenotransplantation.” We note that screening donors for communicable disease risks of Creutzfeldt-Jakob Disease (CJD) and xenotransplantation is done through donor history questions that are part of the screening process. There are currently no tests that can evaluate a donor’s risk for CJD or xenotransplantation.

Failure to follow written procedures describing the handling of all written and oral complaints regarding a drug product [21 CFR 211.198(a)]. For example, the report for consumer complaint CC-000159 related to PalinGen® Flow® indicated that the incident involved a communicable disease and required medical/surgical intervention; however, you did not report this event to FDA within 15 days, as required by your written complaint procedure. We acknowledge receipt of your letters…

Failure to establish written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess [21 CFR 211.100(a)]. Specifically, your firm did not validate the manufacturing processes for PalinGen® Flow® or PalinGen® InovōFlo® with respect to identity, strength, quality, and purity.Your firm's validation protocol is insufficient as it does not include supporting data demonstrating that your firm's manufacturing process can consistently yield expected product characteristics.. Your firm distributed approximately (b)(4) units of PalinGen® Flow® and approximately (b)(4) units of PalinGen® InovFlo® since January 2020 to August 2022. These units were distributed without process validation for these products.