FDA EIR - Quotient Sciences - Philadelphia, LLC - August 16, 2022

A Pre-Approval Inspection (PAI) was conducted by the FDA at Quotient Sciences, located in Garnet Valley, PA, from August 5 to August 16, 2022. The inspection assessed Quotient Sciences' role as a contract manufacturer for a specific drug product, (b)(4) Tablets, (b)(4) mg, under Compliance Program 7346.832. This was the first FDA inspection for the site. The inspection revealed two primary observations detailed on an FDA-483 form. Firstly, equipment used in drug product manufacturing, processing, packing, or holding was found not to be of appropriate design for its intended use. Secondly, the firm failed to thoroughly review unexplained discrepancies, even for batches that had already been distributed. In response, Quotient Sciences' General Manager and Vice President of PHL Operations, David Engers, agreed to provide a written response to the observations within 15 business days. As a result of these findings, the FDA recommended a "Withhold" for Quotient Sciences' manufacturing role concerning the specific drug product reviewed during the PAI.