FDA 483 - Destileria Serralles, Inc. - March 11, 2021

Destileria Serralles, Inc., an OTC drug manufacturer in Mercedita, PR, was cited for numerous significant deficiencies in its quality control, laboratory, materials, and facilities/equipment systems. Repeated observations highlighted the Quality Unit's lack of authority and responsibility, inadequate product testing for active ingredients, and absence of critical procedures for supplier qualification, sampling, SOP revisions, GMP training, expiration dating, and equipment cleaning. These issues indicate a systemic failure to adhere to cGMP requirements for drug product manufacturing and release.