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Talk to a SpecialistTalk to a SpecialistEugia Pharma Specialities Limited, a drug manufacturer in India, violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering their sterile injectable drug products adulterated. During a January-February 2024 inspection, the FDA found that the company failed to ensure complete and accurate laboratory records for production and process simulations, specifically failing to test all integrity parameters required by their own procedures for sterile manufacturing components across multiple batches. Operators did not properly document component leaks and failures or conduct adequate monitoring, and one component that lacked integrity testing subsequently failed during inspection, demonstrating the critical risk of product contamination from these omissions.