FDA 483 - The Ritedose Corporation - March 18, 2022

This FDA Form 483 document outlines an observation made during an inspection, citing a failure to thoroughly review unexplained discrepancies and the failure of a batch or its components to meet specifications, even if distributed. The specific issue identified pertains to the detection of mold species, including *Aspergillus brasiliensis*, within ISO 5 classified areas.

The firm detected mold during four separate monitoring events between January 28, 2021, and November 05, 2021. Six of these events specifically recovered *Aspergillus brasiliensis*. The observation states that the firm did not thoroughly investigate these mold detection events. Furthermore, the firm did not perform adequate actions to correct the identified issues or to prevent their recurrence. This indicates a deficiency in the firm's quality system regarding deviation investigation and corrective and preventive actions (CAPA) related to environmental monitoring excursions in critical manufacturing areas.