FDA EIR - PolarityTE, Inc - July 13, 2018

PolarityTE, Inc. underwent its initial FDA comprehensive Good Manufacturing Practice (GMP) inspection from July 9 to July 13, 2018. The inspection, requested by the Center for Biologics Evaluation and Research, focused on the manufacturing of the company's autologous human tissue product, SkinTE™. This biological drug product is regulated under the Public Health Service and FD&C Acts, specifically 21 CFR Parts 210 and 211. The inspection revealed eight significant observations, highlighting critical deficiencies in the company's operations. Key issues included the absence of written procedures for production and process controls to ensure product quality and purity, and unsuitable building construction that hindered proper cleaning and maintenance. Aseptic processing areas exhibited problems with environmental monitoring and cleaning/disinfection systems. Furthermore, the company lacked a written program for assessing product stability and its quality control unit lacked full authority to investigate errors. Laboratory control mechanisms were not consistently followed or documented, and there were inadequate physical separations to prevent contamination. Additionally, several discussion points were raised, such as the lack of validation for cleaning effectiveness, insufficient control over batch record printing, absence of smoke study videos for aseptic areas, and no documented GMP training for employees. PolarityTE, Inc. committed to providing a written response to all observations within 15 business days, outlining their corrective actions.