FDA 483 - Keshava Organics Private Ltd. - January 13, 2023

Fermenta Organics Private Ltd in Tarapur, India, an API manufacturer, received a Form 483 with two observations. The inspection revealed a lack of written procedures for production and process controls, including missing manufacturing process validation and stability evaluations for recovered drug substance. Additionally, the firm failed to perform impact assessments for stability samples stored in a malfunctioning stability chamber.