FDA 483 - Global Calcium Pvt. Limited

An FDA inspection of Global Calcium Pvt. Limited in Hosur, India, an API manufacturer, revealed severe data integrity issues and multiple GMP violations. The firm was found to be fabricating batch records and other production documentation for US market products, and subsequently deleting related electronic files. Additionally, the company failed to maintain adequate stability testing programs, establish proper impurity profiles, and ensure facility and equipment maintenance to prevent contamination, indicating a systemic breakdown in quality control.