FDA 483 - Quotient Sciences-Miami, Inc - October 27, 2023

During an inspection conducted from October 20-27, 2023, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Quotient Sciences in Garnet Valley, PA. The inspection revealed significant deficiencies related to the firm's manufacturing processes and quality systems, indicating non-compliance with Good Manufacturing Practices as outlined by the Federal Food, Drug and Cosmetic Act.

Two primary observations were noted. First, the company failed to ensure manufacturing equipment was appropriately designed and qualified for its intended use. This included the absence of proposed commercial manufacturing equipment onsite and the failure to conduct representative Performance Qualification (PQ) studies for several critical pieces of equipment, such as tanks, mixers, and tablet presses. The studies performed were deemed inadequate, often not covering the target operating ranges or commercial batch sizes, an issue previously cited in an August 2022 inspection.

Second, Quotient Sciences' written procedures for equipment cleaning and maintenance were found to be deficient. The firm lacked sufficiently detailed descriptions of cleaning methods, materials, and particularly, inadequate worst-case sampling location assessments for shared equipment. This deficiency could compromise the consistency and effectiveness of cleaning verification, failing to ensure that all critical areas of equipment are adequately sampled to prevent cross-contamination.

These observations require Quotient Sciences to implement comprehensive corrective actions to address the identified issues in equipment management, qualification, and cleaning validation to ensure compliance with federal regulations.