Skye Biologics Holdings LLC
FDA issued a warning letter to Skye Biologics Holdings LLC (El Segundo, CA) following a November–December 2022 inspection, finding that its umbilical cord-derived 'placental connective tissue matrix allograft' products (BioECM™ line) are unapproved new drugs and unlicensed biological products marketed without a valid Biologics License Application (BLA). The products were found to exceed minimal manipulation thresholds and were not intended for homologous use, disqualifying them from regulation solely under PHS Act section 361. FDA also documented seven categories of significant CGMP violations, including lack of process validation, inadequate environmental monitoring, missing endotoxin testing, and unsupported five-year expiration dating. FDA warned that failure to adequately respond may result in seizure and/or injunction.
Flagged claims (2)
Placental tissues have been shown in the literature to be naturally anti-inflammatory, anti-fibrotic, anti-microbial, to modulate inflammation, promote tissue remodeling and reduce scar tissue formation in clinical applications.
FastActing Amniotic Membranes are part of HRT's & Skye's extensive line of amniotic and placental products designed to help support proper tissue remodeling while modulating scarring and inflammation.
Required actions (2)
We request that you respond in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to correct any violations, including an explanation of how you plan to prevent any violations, or similar violations, from occurring again.
Failure to adequately address these matters may lead to regulatory action without further notice. Such actions may include seizure and/or injunction.
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