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Talk to a SpecialistTalk to a SpecialistGlobal Calcium Pvt. Limited, an active pharmaceutical ingredient (API) manufacturer in India, received a warning letter for significant Current Good Manufacturing Practice (CGMP) violations that rendered their APIs adulterated. FDA inspectors found critical quality unit failures including simultaneous manufacturing of different APIs on the same equipment without proper documentation and the deletion of multiple electronic records (such as cleaning validation samples and production reports) during the inspection itself. The company's batch records and equipment logbooks demonstrated inadequate controls and documentation practices that violated FDA manufacturing standards for drug production.