FDA 483 - Sterigenics US, LLC - August 23, 2022

From August 17 to August 23, 2022, the FDA conducted an inspection of Sterigenics US, LLC, a contract sterilization facility located in Fort Worth, Texas. The inspection, conducted under Section 704(b) of the Federal Food, Drug, and Cosmetic (FD&C) Act, identified several significant failures in the firm"s laboratory and quality systems. Specifically, investigators found that laboratory personnel failed to document or justify deviations from written test procedures. This included repeating equipment accuracy tests until they passed without the required investigations, which is concerning as this data supports the sterilization certification of drug products. Additionally, the Quality Control Unit repeatedly failed to follow its own internal timelines for investigating deviations and closing Corrective and Preventive Actions (CAPAs). The firm also failed to adhere to its procedures for handling customer complaints, leaving at least seventeen complaints unresolved beyond the established deadlines. These observations represent objectionable conditions observed during the inspection but do not constitute a final regulatory determination. Sterigenics is required to address these findings by providing the FDA with a written response detailing their corrective actions or any objections to the observations to ensure the facility meets safety and quality standards.