FDA EIR - PolarityTE, Inc - July 13, 2018

The FDA conducted a comprehensive Good Manufacturing Practices (GMP) inspection of PolarityTE, Inc. from July 9-13, 2018, focusing on their SkinTE™ autologous human tissue product. Regulated under Public Health Service and Food, Drug, and Cosmetic Acts for biological drug products, this initial inspection identified significant deficiencies across multiple systems, including quality, facilities, production, and laboratory controls. Eight official observations (FDA-483s) were issued. Key issues included the absence of written procedures for production and process controls, inadequate building construction and environmental monitoring in aseptic areas, lack of a stability testing program, insufficient quality control authority, and failure to follow and document laboratory controls. Additionally, discussion items noted missing cleaning validation, incomplete batch record control, absence of smoke study videos for airflow, lack of incoming material certificate of analysis evaluation, and no documented GMP training for employees. PolarityTE, Inc. is required to submit a written response addressing these observations within 15 business days.