FDA 483 - Duchesnay Inc. - October 27, 2023

Duchesnay Inc., a nonsterile finished drug product manufacturer in Blainville, was inspected by the FDA from October 23-27, 2023. The inspection revealed a significant deficiency in the firm's production and process controls. Specifically, the company failed to establish adequate written procedures and critical process parameters for its tableting operations, impacting the assurance of drug product identity, strength, purity, and quality.