Quotient Sciences - Philadelphia, LLC – FDA 483, Oct 27, 2023

On October 27, 2023, the FDA issued a Form 483 to Quotient Sciences, a manufacturer located at 3080 Mccann Farm Dr, Garnet Valley, PA. The inspection, conducted from October 20-27, 2023, identified two primary observations.

Observation 1 details issues with equipment design and qualification. Specifically, equipment proposed for commercial manufacturing, including a [REDACTED] Tank and [REDACTED] Mixer (ID #[REDACTED]) and a [REDACTED] Tablet Press (ID #[REDACTED]), was not installed onsite. Furthermore, the firm failed to perform representative Performance Qualification (PQ) studies for several pieces of equipment used in manufacturing [REDACTED]. IQ/OQ studies for [REDACTED] and [REDACTED] were run at a [REDACTED] and did not demonstrate operation at the target [REDACTED] setting of [REDACTED] or the operating range of [REDACTED] as specified in the Master Batch Record. PQ studies for the [REDACTED]™ (ID #[REDACTED]), [REDACTED] (ID #[REDACTED]), and [REDACTED] (ID #[REDACTED]) were also deemed inadequate, failing to demonstrate intended operation for commercial scale batch sizes. This observation is a repeat from a previous FDA 483 issued on August 1