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

An FDA inspection of Quotient Sciences' Boothwyn, PA facility, a contract development and manufacturing organization for non-sterile human drugs, was conducted from December 14-22, 2022. This cGMP inspection identified several deficiencies impacting product quality and integrity. The primary observation, documented on a Form FDA 483, concerned the inadequate cleaning and sanitization of equipment and utensils at appropriate intervals, failing to prevent contamination. Further issues related to the cleaning program included an outdated clean equipment hold time study from 2013, which did not encompass newer manufacturing equipment, and the absence of a formal assessment to justify swab sample locations as representative of the most difficult-to-clean areas. Inspectors also noted a recurring trend of failures in executing cleaning verifications without adequate corrective and preventive actions. Verbal discussions highlighted additional concerns, such as the lack of separate or defined areas and control systems necessary to mitigate cross-contamination, particularly for potent compounds stored alongside non-potent materials, and the movement of balances/scales between potent and non-potent areas without dedicated use. Other deficiencies included insufficient written procedures for reviewing computerized audit trails and metadata, inadequate frequency of data review, and incomplete documentation for manufacturing equipment transferred between their Boothwyn and Garnet Valley sites. Quotient Sciences' management acknowledged these observations and committed to providing a voluntary written response to the agency within 15 business days, outlining their planned corrective actions.