Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistSyntec Pharma Corp's drug manufacturing facility received a warning for significant current good manufacturing practice (CGMP) violations involving active pharmaceutical ingredients (APIs), which rendered their products adulterated. FDA inspectors found critical control failures including inadequate prevention of cross-contamination between APIs, use of non-dedicated equipment in shared spaces, and undocumented repackaging activities of highly potent cytotoxic agents like Lomustine without proper batch records or equipment logs. The company initially denied performing repackaging of potent APIs but later acknowledged engaging in these operations without maintaining required documentation or appropriate procedures.