FDA 483 - Glenfin Chemicals Private Ltd. - August 19, 2022

An FDA inspection of Glenfin Chemicals Private Ltd. in Thane, Maharashtra, India, from August 16-19, 2022, identified two significant observations. The firm was cited for inadequate written procedures for raw material sampling and testing, and for failing to ensure the completeness and proper review of production batch records. These findings highlight deficiencies in the company's quality control and documentation practices.