FDA WARNING_LETTER - Stemell Inc - March 08, 2019

On August 28, 2019, the FDA issued a Warning Letter to Stemell, Inc. following an inspection from March 4-8, 2019. The FDA determined Stemell's umbilical cord products, StemL UCB-Plus™ and StemL UCT-Plus™, are unapproved drugs and biological products, not solely regulated as HCT/Ps under 21 CFR Part 1271, because they fail to meet homologous use and minimal manipulation criteria.

The products lack an approved biologics license application (BLA) and an effective investigational new drug (IND) application, violating the FD&C Act and PHS Act.

The inspection also revealed significant deviations from current good manufacturing practice (CGMP) and current good tissue practice (CGTP), posing safety concerns due to potential contamination. Deficiencies include: * Failure to document donor eligibility (21 CFR 1271.50(a)). * Lack of established procedures for donor eligibility determination (21 CFR 1271.47(a)). * Failure to prevent microbiological contamination, including unvalidated aseptic processes, inadequate aseptic practices, uninvestigated environmental monitoring excursions, and improper handling of multi-use sterile containers (21 CFR 211.113(b)). * Inadequate environmental controls, including insufficient environmental and personnel monitoring, unvalidated cleaning procedures, and