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Talk to a SpecialistTalk to a SpecialistMentha & Allied Products Private Ltd., an Indian API manufacturer, was cited for significant Current Good Manufacturing Practice (CGMP) violations that rendered their active pharmaceutical ingredients adulterated. FDA inspectors found critical deficiencies including failure to maintain facility sanitation (soiled washrooms lacking soap, dirty gowning areas), use of visibly soiled cloth gloves without documented cleaning procedures, and inadequate equipment cleaning and maintenance procedures. The company's December 2024 response to the FDA Form 483 was determined inadequate due to lack of supporting documentation and insufficient evidence of corrective actions to achieve CGMP compliance.