FDA 483 - QPS, LLC - January 30, 2026

From January 27 to January 30, 2026, the FDA inspected QPS, LLC, a biopharmaceutical analytical facility located in Newark, Delaware. The inspection identified two primary concerns regarding the company’s adherence to its own internal protocols and data documentation practices. First, the firm failed to follow its established standard operating procedures for sample analysis. Specifically, a study sample was mistakenly re-assayed and then repeated three additional times, a practice that directly contradicted the company"s internal guidelines for testing consistency. Second, investigators discovered significant discrepancies in records used to validate testing methods. Source documentation lacked specific details regarding the aliquots used during freeze-thaw cycles, making it impossible to accurately reconstruct the validation data. These observations were issued under the Federal Food, Drug, and Cosmetic Act to assist the firm in reaching full compliance. While these findings do not represent a final agency determination, QPS, LLC is required to address these issues. The company should provide a formal response to the FDA detailing its completed or planned corrective actions. Ensuring that analytical methods are rigorously documented and that staff strictly follow internal procedures is essential for maintaining the integrity of the facility"s biopharmaceutical research.