FDA 483 - Island Testing and Technical Services LLC - October 01, 2025

During an inspection conducted from September 22 to October 1, 2025, the U.S. Food and Drug Administration (FDA) identified significant observations at LLC in Stony Brook, NY. The inspection revealed two primary issues related to quality control and equipment suitability for drug product manufacturing.Firstly, the company's quality control unit did not fully adhere to its established procedures for laboratory record-keeping. Despite a written standard operating procedure (SOP #008) requiring the issuance of laboratory notebooks, none were observed or provided during the inspection. Instead, uncontrolled data sheets were being used to document raw analytical results from drug product testing, raising concerns about data integrity and traceability.Secondly, the equipment utilized in drug product operations was deemed inappropriate for its intended purpose. A Digital Colony Counter, used for microbial colony counting, lacked the capability to save or securely transfer data digitally. Furthermore, the firm did not maintain a secure digital storage system for this critical data. These deficiencies highlight potential risks to data accuracy and the overall quality assurance process.These observations, issued under the authority of the Federal Food, Drug and Cosmetic Act, indicate deviations from expected good manufacturing practices. LLC is expected to promptly address these findings by investigating the root causes, implementing effective corrective and preventive actions, and ensuring full compliance with regulatory requirements to safeguard drug product quality and patient safety.