Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistHikal Limited, an active pharmaceutical ingredient (API) manufacturer in India, was found to have significant Current Good Manufacturing Practice (CGMP) violations that rendered their APIs adulterated. During a February 2025 inspection, the FDA identified critical failures in the company's quality unit, including inadequate investigation and root cause determination for approximately 22 metal contamination complaints in APIs since 2020. Notably, the firm failed to properly qualify its metal detection equipment to identify metallic particles from manufacturing equipment, and in one case dismissed contamination as "technically unavoidable" without establishing a genuine root cause.