FDA 483 - Quotient Sciences - Philadelphia, LLC - September 17, 2025

Quotient Sciences - Philadelphia, LLC received an FDA Form 483 following an inspection conducted from September 8 to September 17, 2025. The observations highlight significant concerns regarding manufacturing controls and adherence to Good Manufacturing Practices (GMP) for drug products.

Key issues included a failure to follow written procedures for equipment cleaning and maintenance. Investigators observed white residue on equipment designated as clean, which is used for potent and investigational drug products. The firm’s cleaning validation protocol for this equipment was not properly executed, specifically regarding visual inspection techniques.

Furthermore, the company did not adequately prevent contamination through its cleaning processes. The firm’s risk assessment for cleaning validation lacked scientific justification for swab locations and consistent sampling site descriptions, a deficiency noted as a repeat observation from a 2022 inspection.

Personnel practices also posed contamination risks. Inspectors documented instances of operators removing beard covers and unzipping protective suits to use cell phones within processing rooms, directly violating the firm’s established gowning procedures designed to protect drug products from contamination.

Under the Federal Food, Drug, and Cosmetic Act, Quotient Sciences is required to address these conditions to ensure drug products are not prepared or held under insanitary conditions. The firm must implement comprehensive corrective and preventive actions, including revising and enforcing cleaning validation protocols, strengthening equipment maintenance, and ensuring strict adherence to gowning procedures, to prevent recurrence and maintain product quality and safety.