FDA 483 - Creative Testing Solutions - August 29, 2025

Creative Testing Solutions, a testing laboratory located in Tempe, Arizona, underwent an FDA inspection from August 18 to August 29, 2025. The inspection identified two major areas of concern regarding the facility"s adherence to testing protocols and quality management systems. First, the laboratory failed to follow manufacturer instructions during testing for communicable diseases. Specifically, technicians used unauthorized reagent reservoirs and utilized an unvalidated, undocumented cleaning process for these reservoirs. This deviation impacted several critical diagnostic tests, including those for HIV and Hepatitis B. Second, the firm failed to perform thorough investigations into unexplained discrepancies. The laboratory"s internal procedures were found to be insufficient, as they only required investigations for customer complaints or errors in already released results. A specific instance was noted where incorrect quality control lot numbers were used for donor serum protein electrophoresis, yet the facility failed to document the discovery, the scope of the error, or the justification for accepting the affected test results. These observations were issued under the regulatory framework of the Federal Food, Drug, and Cosmetic Act. While the report does not represent a final compliance determination, the company is expected to implement corrective actions and provide a formal response to the FDA to address these deficiencies.