FDA 483 - PolarityTE, Inc - July 13, 2018

An FDA inspection was conducted at PolarityTE, Inc., a biological drug manufacturer located in Salt Lake City, UT, from July 9-13, 2018. This comprehensive GMP inspection, requested by the Center for Biologics Evaluation and Research, focused on the manufacturing of the firm’s SkinTE™ autologous human tissue product, operating under the PHS and FD&C Acts, including 21 CFR 211 and 1271. The inspection identified eight FDA-483 observations and several additional discussion items. Noteworthy violations included the absence of written procedures for production and process controls essential for ensuring drug product identity, strength, quality, and purity. Significant deficiencies were also found in the facility’s construction, hindering proper cleaning and maintenance, and in aseptic processing areas regarding environmental monitoring, cleaning, and disinfection systems. The firm lacked a written program for assessing drug product stability, a documented GMP training program for employees, and the quality control unit showed insufficient authority to thoroughly investigate errors. Furthermore, laboratory control mechanisms were not consistently followed or documented, and adequate separate areas to prevent contamination or mix-ups were deficient. PolarityTE, Inc. committed to providing a written response to all observations within 15 business days.