FDA WARNING_LETTER - Cord for Life, Inc. - November 30, 2018

On March 29, 2019, the FDA issued a Warning Letter to Cord for Life, Inc. following an inspection from November 26-30, 2018. The inspection revealed that the firm's human umbilical cord blood products (PremierMaxCB Platinum, Gold, and Silver), marketed for "therapeutic uses" like orthopedic conditions, are considered unapproved drugs and biological products under the FD&C Act and PHS Act. They do not qualify for HCT/P exceptions as they are not for homologous use and are dependent on metabolic activity of living cells for their primary function, without being for autologous, related allogeneic, or reproductive use.

The firm lacks an approved biologics license or an Investigational New Drug (IND) application. Additionally, significant Current Good Manufacturing Practice (CGMP) deviations were observed, posing potential safety concerns due to unvalidated processes, uncontrolled environments, and inadequate aseptic practices. Deficiencies include failure to prevent microbiological contamination (e.g., unvalidated aseptic process, poor personnel practices, positive microbial samples without investigation), inadequate environmental monitoring (e.g., infrequent monitoring, non-representative samples, lack of alert/action limits), unvalidated cleaning procedures for equipment, unvalidated manufacturing processes, and insufficient laboratory controls (e.g., no specifications for identity, strength, quality, purity; inadequate sterility testing). The firm also assigns a three-year expiration date without supporting stability data.

The FDA