FDA 483 - Quotient Sciences - Philadelphia, LLC - December 22, 2022

The FDA inspected Quotient Sciences - Philadelphia, LLC, a drug manufacturer, and found deficiencies in their equipment cleaning and sanitization practices. The firm failed to conduct updated clean equipment hold time studies for new major manufacturing equipment and lacked formal justification for worst-case swab sampling locations in cleaning validation studies. These issues indicate potential risks to the safety, identity, strength, quality, or purity of drug products.