483
Keshava Organics Private Ltd.Keshava Organics Private Ltd. – FDA 483, Jan 13, 2023
Record Details
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.
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ID · 2d64611a-9188-481e-ba3d-aeb7e534ce08
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