Kimera Labs, Inc. – FDA Warning Letter, Jul 21, 2022

The FDA issued a Warning Letter to Kimera Labs, Inc. following a July 2022 inspection, identifying their exosome products (XoGlo®, XoGlo®Pro) and amniotic fluid product (Amnio2X®) as unapproved drugs and biological products. These products require a valid biologics license or an Investigational New Drug (IND) application for lawful marketing. The firm was found to be commercially distributing XoGlo®Pro, despite having an IND, which violates 21 CFR 312.7(b). Kimera Labs continued to manufacture and distribute XoGlo® and XoGlo®Pro for human disease treatment without an approved BLA or IND, even after a prior Untitled Letter in April 2020.

Significant Current Good Manufacturing Practice (CGMP) deviations were documented, affecting over 37,000 vials. These include failures in establishing procedures for preventing microbiological contamination and validating aseptic processes (21 CFR 211.113(b)), inadequate investigation of discrepancies (21 CFR 211.192), insufficient sterility testing (21 CFR 211.167(a)), lack of scientifically sound specifications (21 CFR 211.160(b)), unvalidated production processes (21 CFR 211.100(a)), failure to test for penicillin cross-contamination (21 CFR 211.176), inadequate cleaning and disinfection systems (21 CFR 211.42(c)(10)(v)), unvalidated test methods (21 CFR 211.165(e)), failure to test and release components by quality control (21 CFR 211.84(a)), and lack of a stability testing program to determine expiration dates (21 CFR 211.166(a)).

Kimera's responses to the FDA-483 were deemed inadequate. The FDA requested a written response within fifteen working days outlining specific corrective actions and prevention plans, warning of potential regulatory actions like seizure or injunction for non-compliance. The FDA also highlighted a public safety notification regarding exosome products due to serious adverse events.