FDA 483 - CellRight Technologies LLC - July 25, 2024

During an inspection conducted from July 15-25, 2024, the FDA issued a Form 483 to CellRight Technologies LLC, a human tissue processor located in Universal City, TX. The inspection revealed several significant observations pertaining to the company's manufacturing and quality control systems for its skin graft products, including DermaPure, VNEW, and Matrix ND. The primary issues identified include a failure to validate manufacturing processes, specifically for the dCell Dermis procedure, which is critical for ensuring product quality and consistency. Additionally, the firm exhibited deficient component testing practices. Raw materials, some explicitly labeled "For Research Only," were incorporated into products without adequate verification of their purity, potency, or pH, as stated in supplier certificates of analysis. Finally, the inspection noted that procedures designed to prevent microbiological contamination of purportedly sterile drug products were not consistently followed. A specific work instruction for dCell Dermis production was found to be inconsistent with the approved validation document, particularly concerning crucial treatment steps. These observations indicate a need for CellRight Technologies LLC to strengthen its adherence to regulatory frameworks governing the production of human tissue products. The company is required to implement comprehensive corrective actions to address these deficiencies, validate its manufacturing processes, improve raw material testing, and ensure consistent application of contamination control procedures to maintain product safety and quality.