FDA 483 - Matrixx Initiatives Inc - May 28, 2009

This FDA Form 483 document details an inspection finding related to the reporting of serious adverse events for a non-prescription drug used in the United States. The core observation is that the firm has failed to report serious adverse events to the Secretary, specifically regarding anosmia (loss of smell) and loss of taste. The firm does not classify these conditions as serious adverse events, leading to their omission from reports to the Food and Drug Administration (FDA) via the MedWatch reporting system.

The document cites three specific complaint numbers that were not reported to the FDA's MedWatch system: A509-000723, A509-000736, and A509-000886. This indicates a deficiency in the firm's pharmacovigilance and adverse event reporting procedures, particularly concerning the classification and subsequent reporting of sensory loss complaints. The implication is that the firm's quality system for post-market surveillance and regulatory compliance is inadequate in this area, potentially underreporting significant adverse reactions associated with their non-prescription drug product.