Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistProfounda, Inc. was cited for significant Current Good Manufacturing Practice (CGMP) violations in the manufacturing of over-the-counter drug products, including "Rhinase D" and "Rhinase." During an August 2022 inspection, the FDA found that the company failed to establish written procedures for production and process control and lacked validation data, qualification protocols, and studies to demonstrate that its manufacturing processes were in a state of control with appropriate acceptance criteria. The company's response proposing a single validation report for both products was deemed inadequate because the products contain different active ingredients and therefore require separate validation documentation.