Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
Talk to a SpecialistLoading…
Talk to a SpecialistTalk to a SpecialistBhargava Phytolab Private Limited, a drug manufacturer in India, violated Current Good Manufacturing Practice (CGMP) regulations for both finished pharmaceuticals and active pharmaceutical ingredients (APIs). During a July 2024 inspection, the FDA identified significant testing failures, including inadequate laboratory testing for API batches and failure to determine conformance to specifications—particularly for potentially toxic ingredients where limit testing was not performed. The company's reliance on supplier certificates of analysis without conducting independent verification was deemed insufficient to ensure product quality and safety. These violations rendered the company's drugs adulterated under the Federal Food, Drug, and Cosmetic Act.