FDA Hits Florida Stem Cell Treatment Company for GMP Deviations
The FDA slammed Altamonte Springs, Florida stem cell product manufacturer Cord for Life in a warning letter over GMP violations and failing to meet regulatory requirements.
The agency inspected the facility from Nov. 26-30, 2018, citing the firm for its human umbilical cord blood derived cellular products, which it determined were unlawfully marketed. The company referred to them as “regenerative products” and “regenerative medicine products” and said they were intended for “therapeutic uses” — meaning the FDA regulated them as drugs.
Cord for Life didn’t possess a valid biologics license or an investigational new drug application for the products.
The FDA flagged numerous GMP issues, such as personnel practices that risked microbiological contamination. For example, operators were seen reusing non-sterile smocks for up to two weeks, wearing non-sterile gloves in ISO 5 biosafety cabinets, and failing to use hair covers, masks and goggles. Operators were also seen wearing watches and exposing skin during processing operations in biosafety cabinets.