FDA 483 - BLS Labs, LLC - September 03, 2021

BioLab Sciences, Inc. in Scottsdale, AZ, a stem cell manufacturer, was cited with 11 observations during an FDA inspection from August 23 to September 3, 2021. The observations primarily concern significant deficiencies in aseptic processing validation, process controls, component handling, stability data, and HCT/P storage and shipping conditions for their injectable amniotic fluid products, MyOwnSkin, and amniotic membrane products. These issues indicate a lack of adequate controls to ensure the sterility, quality, and purity of their distributed drug products and HCT/Ps.