FDA 483 - PolarityTE, Inc - July 13, 2018

PolarityTE, Inc. in Salt Lake City, UT, a biological drug establishment, was inspected by the FDA from July 9-13, 2018. The inspection revealed significant deficiencies in production and process controls, environmental monitoring, facility design, and quality control for their SkinTE product. These issues indicate a lack of adequate procedures and documentation to ensure product identity, strength, quality, and purity, raising concerns about aseptic processing and contamination control.