FDA 483 - Gopaldas Visram & Co., Ltd. - January 24, 2025

An FDA inspection of Gopaldas Visram & Co., Ltd. in Navi Mumbai, India, a drug manufacturer, revealed significant deficiencies across multiple areas. The firm failed to adequately test raw material components before use and lacked proper controls over electronic records, leading to data integrity concerns. Additionally, the quality control unit did not fully adhere to its procedures, and the company inappropriately used "planned deviations" to bypass protocols, indicating serious lapses in quality management and record-keeping practices.