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Talk to a SpecialistTalk to a SpecialistCdymax India Pharma Private Limited, an API manufacturer in Bangalore, India, was cited for significant Current Good Manufacturing Practice (CGMP) violations that rendered their active pharmaceutical ingredients adulterated. During an April 2025 inspection, FDA investigators found that the company failed to adequately investigate and document approximately 1,500 out-of-specification (OOS) results and laboratory incidents since 2023, with investigations frequently lacking thorough root cause analysis and appropriate corrective and preventive actions (CAPAs). These deficiencies were particularly concerning given that the company manufactures APIs for parenteral drug products intended for human use.