Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
Talk to a SpecialistLoading…
Talk to a SpecialistTalk to a SpecialistThai Nakorn Patana Co., Ltd., a Thai pharmaceutical manufacturer, was cited for Current Good Manufacturing Practice (CGMP) violations in the production of over-the-counter drug products. During an FDA inspection in July-August 2023, the firm failed to perform adequate laboratory testing to confirm the identity and strength of active ingredients in finished drug batches prior to release and distribution. The company's response to initial FDA findings was deemed insufficient because it lacked detailed testing procedures and risk assessments for products already released without appropriate assay validation. These failures rendered the firm's drug products adulterated under federal law.